MEDICAL DEVICES RECALL LISTINGS: 2009

Trade Name Manufacturer Recall Posting Date Recall Start Date Recall Number Hazard Classification Model or Catalog # Lot or Serial # Reason for Recall

A) Innova 2100 IQ Digital Imaging SystemB) Innova 4100 IQ System

GE Healthcare 2009-01-05 2008-01-03 39234 Type II A) 2335129-4B) 2335129-3

A) S/N 515959BU5, 518373BU6, 534731BU5, 476532BU7, 482422BU3B) S/N 491354BU7 & 508964BU4

During acquisition (fluoro &/or record), an image could become frozen on DL (digital leader acquisition system) live monitor screen, leading the user to believe it was a live dynamic image instead.

Colleague Volumetric Infusion Pump Baxter Healthcare Corporation 2009-01-05 2008-03-13 41402 Type II 2M8151K >10 Numbers, Contact Mfr. Product fitted with incorrect power cord (220v versus 120v) and not labelled as certified to the Canadian electrical requirement CAN/CSA C22.2 no.601.1.

Light Wand Orotracheal Lighted Stylet Vital Signs Inc. 2009-01-05 2008-08-11 43632 Type II 3910, 3960, INTPKF >10 Numbers, Contact Mfr. There is a possibility that the light bulb protector (clear plastic bulb cover) on the end of the stylet may detach from the stylet.

ReSolve Open Back Halo Ring Ossur HF 2009-01-05 2008-11-12 45100 Type II 505400D 8040201 The 5/16-24 class 3B threads in the Open Back Halo Rings were tapped with the wrong size or worn taps and do not pass the "go" thread plug gage.

Process System Manager Roche Diagnostics Ltd. 2009-01-05 2008-12-12 45358 Type I 3009696001 VERSION 2.00.02a to 2.01.05a/b Potential for a result to be released to the host (LIS/laboratory information system) before a post analytical rule (namely car rule) is triggered to block the result.

Magellan Platelet Separator Disposables Medtronic Inc. 2009-01-05 2008-08-19 45455 Type II BOS370, COS330, MDK300, MDK305 >10 Numbers, Contact Mfr. Becton Dickinson, a supplier of syringes, notified Medtronic that unit package seal integrity (hence sterility) can be adversely affected when exposed to low atmospheric pressure. Syringes are included in kits.

Reservoirs Maquet Cardiopulmonary AG 2009-01-05 2008-11-18 45565 Type II BEQ-VHK 2001 276339, Heparin Lot PH64507 Celsus heparin was used during the coating process, manufactured from material that was found to contain the contaminant over-sulfate chondroitin sulfate (OSCS), which mimics heparin's anticoagulant activity.

Cell-Dyn Sapphire Analyzer Abbott Laboratories Diagnostic Division 2009-01-05 2008-12-12 45612 Type III 8H00-01 Cell-Dyn Sappire Hemoglobin Reagent Syringes (08H49-02) Labelled With Packaged Dates Of 16 Sept 2008.

Cell-Dyn Sapphire 5.0ml hemoglobin reagent syringes were manufactured with a 2.5ml syringe pull instead of the correct 5.0ml syringe pull.

A) Philips Multidiagnost Eleva - Image IntensifierB) Philips Multidiagnost Eleva - Flat DetectorC) Omnidiagnost Eleva

Philips Medical Systems Nederland B.V. 2009-01-05 2008-11-26 45311 Type II A) 70832B) 70834C) 708027

A) N/AB) N/AC) N/A

A partial grid-switch failure may occur that may result in a higher x-ray dose than expected.

A) Origin YZ Zirconia BlocksB) Origin YZ Zirconia Discs

White Peaks Dental Systems 2009-01-05 2008-11-26 44705 Type II A) N/AB) N/A

A) >10 Numbers, Contact Mfr.B) >10 Numbers, Contact Mfr.

The product does not have a Health Canada device licence as per section 26 of the MDR. As a result, a recall was issued.

Precision Charger 1.0 Boston Scientific Neuromodulation Corporation 2009-01-05 2008-09-26 45208 Type II N/A >10 Numbers, Contact Mfr. The recall is issued due to reports of burns while using the device. The burns occurred in the area of charging, typically at the abdominal, upper buttock, and less frequently in the subclavicular area.

Dri-Lok Disposable Cannulas Stryker Endoscopy 2009-01-05 2008-12-11 45616 Type II 3910-075-500, 3910-075-501, 3910-075-502, 3910-075-650, 3910-075-651, 3910-075-652, 3910-075-800, 3910-075-801, 3910-075-802, 3910-090-500, 3910-090-502, 3910-090-650, 3910-090-652, 3910-090-800, 3910-090-802

08 135 AG2 - 08 294 AG2 The cannulas leak water when inserted and continue to leak when removed. There has been a change in material without Stryker's approval. The new material has different properties allowing the cannulas to leak.

HM Reaction Vessels Siemens Healthcare Diagnostics Inc. 2009-01-05 2008-11-25 45624 Type III RXV1A NC16-182-08, NC16-210-08, NC16-238-08, NC16-189-08, NC16-217-08, NC16-245-08, NC16-196-08, NC16-224-08, NC16-203-08, NC16-231-08

Siemens Healthcare Diagnostics received customer complaints regarding reaction vessels which are leaking while running HM methods.

Tenderflow Pediatric Arterial Cannula Terumo Cardiovascular Systems Corp. 2009-01-05 2008-11-11 44891 Type II 813570, 813572 0502200 0513069 0507121 0512918 Difficulty retracting the introducer of Tenderflow Pediatric Arterial Cannula. Vertier Surgical Table Stryker Communications 2009-01-05 2008-12-08 45617 Type II 0788-100-001S 080118-43529 The Vertier Table was manufactured with bronze bushings at the tilt shaft instead of the

validated teflon coated bushings. The bronze bushings may fail due to fatigue.A) Simview 3000B) Simview NT Therapy Simulator

Siemens Medical Solutions USA, Inc. Oncology Care Systems

2009-01-05 2008-12-11 45619 Type II A) 1957153B) 5496992

A) 4034, 4011B) 6037, 6038

The company has become aware of a potential for serious patient injury due to excessive wear that may occur to the drive belts used in the image intensifier and/or x-ray head drive mechanisms.

A) ErgoliftB) Ergolift-2

BHM Medical Inc. 2009-01-05 2008-12-08 45626 Type I A) N/AB) N/A

A) ERLI 0001 To ERLI 1717B) ERLI 0001 To ERLI 1717

BHM received incident reports describing a failure of the structure of the boom. The weakening of the welded joint due to excessive grinding may have caused the fatigue failure.

Servo 300/300A Maquet Critical Care AB 2009-01-05 2008-12-17 45668 Type II 6079300, 6079391, 6079433, 6150614, 6424704, 6424712, 6424779

>10 Numbers, Contact Mfr. Short inspiratory times when using Servo Ventilator 300 automode in neonatal and pediatric patient ranges.

A) Roche Hitachi - HDL CholesterolB) Hitachi HDL-C Plus, 3rd GenerationC) Cobas C/Integra HDL-C Gen. 3D) Cobas C 111 HDL-Cholesterol Plus

Roche Diagnostics GMBH 2009-01-05 2008-12-04 44645 Type III A) 04713257190B) 04713109190, 04713184190, 04713214190, 04713265190C) 04399803190D) 04657560190

A) 697427-01B) 695354-01, 697430-01, 696347-01, 697431-01, 697411-01, 696342-01, 697408-01C) 695358-01, 696351-01, 601823-01, 694563-01D) 694566-01

Some HDLC3 reagent lots may generate a decrease in control recovery and an invalid calibration due to calibration factor drift.

A) AutostainerB) Rabbit Monoclonal Antibody Clone SP3

Labvision Corporation - Part Of Thermo Fisher Scientific 2009-01-05 2008-07-16 44328 Type III A) 360-2D, 480-2D, 720-2DB) RM-9103-S, RM-9103-S0, RM-9103-S1

A) All LotsB) All Lots

The importer was selling research use only devices for clinical purposes.

Conform XT- Gloves Ansell Healthcare Products LLC 2009-01-05 2008-11-20 45563 Type II 69318 All Lots Unlicensed class II medical devices.

Autologous Platelet Concentrate System Harvest Technologies Corp. 2009-01-05 2008-10-24 45706 Type II APC-20I APC20i-0006 Lot APC20i-0006 failed the quarterly dose audit for sterility. STA-Neoplastine CI Plus 10 Diagnostica Stago SAS 2009-01-05 2008-10-23 44571 Type II 667 100413, 100805, 100974, 101114, 101511,

101677, 101714, 101769, 101854, 101989, 101576

A potential lack of homogeneity between product vials attributed to a defective excipient in the affected lots of products. This can impact the clotting time performance with the outcome being longer.

Hamilton Star Archive Plate Hamilton Medical AG 2009-01-05 2008-06-01 45089 Type III 04639634001, 235656 2732709, 2742732, 2742744, 2714721, 2810259, 2811269

The barcode label on the Star Archive Plates used with the Cobas S201 system may not be readable by either the Hamilton Star onboard barcode scanner or a hand held scanner.

Anti-H Lectin Dominion Biologicals Ltd. 2009-01-05 2008-09-30 45736 Type III 0141-0015 HL14301 Complaint received from a customer indicating that the product was received with an incorrect directions for use in the package sleeve (packaged with directions for use for anti-a1 lectin).

Intertan Entry Portal Handle Smith & Nephew, Inc. 2009-01-19 2008-12-15 45713 Type II 7167-4092 > 10 Numbers, Contact Mfr. Debris could build up inside of the instrument to the point that it is unusable if it becomes heavily soiled. The instrument is designed to remain outside the body and should not become heavily soiled.

Medfusion Syringe Pump Smith's Medical MD Inc. 2009-01-19 2008-12-29 45802 Type II 3500-306, 3500-415 >100 Numbers, Contact Mfr. An increased trend in reports of keypad issues occurring during implementation or shortly after being placed in use. Short circuits in the keypad may make pump inoperable or pump may not respond to keystrokes.

QP2508 Hand Pendant M.C. Healthcare Products Inc. 2009-01-19 2008-12-05 45786 Type II HB43-U010-00/01 N/A The QP2508 hand pendant has experienced a run on condition. The linear actuator motor continues to run until end of its stroke after releasing the push button on hand pendant and then stops.

Biophen Heparin 6 ref 221006 Hyphen Biomed 2009-01-19 2008-11-25 45340 Type III 221006 80401, 81701, 83306 Biophen Heparin 6 lots contain a substrate reagent (R1) that is harder to dissolve than usually.

ECC.O Integrated Mini-Bypass System Sorin Group Italia S.R.L. 2009-01-19 2008-12-31 45809 Type II 084221, 085339 > 10 Numbers, Contact Mfr. Sorin Group Italia received reports of restricted or blocked flow at the outlet of the mini-bypass bag adopted into perfusion tubing sets designed for mini-bypass systems for the models and lots specified.

Trupath Biopsy Device Boston Scientific Corporation 2009-01-19 2008-10-22 44611 Type III N/A > 50 Numbers, Contact Mfr. Difficulty cocking or arming the cannula latch on the device. This difficulty may result in an inability to use the device. It was determined that the difficulty is related to specific manufactured lots.

Maestro 3000 Cardiac Ablation Foot SWT Boston Scientific Corporation 2009-01-19 2008-11-26 45615 Type II M004218400 > 100 Numbers, Contact Mfr. Discovered a short in the foot switch connector. It is possible that delivery of RF energy can begin without depressing the foot switch.

Nexgen Complete Knee Solution, Articula Zimmer Inc. 2009-01-19 2008-12-19 45916 Type II 00-5971-050-12, 00-5971-050-14 60969810, 60969811, 61007188, 60987590, 60969807, 60976981, 60976982

Some lots of 12mm thick and 14mm thick provisional devices may have become commingled during manufacturing. Some units which are 12mm thick may be etched and packaged as 14mm thick provisionals and vice versa.

Gold Probe Electrohemostatic Catheter Boston Scientific Corporation 2009-01-19 2008-12-31 45864 Type II 6007, 6010, 6012 M00560070, M00560071, M00560100, M00560101, M00560220

Some of the packaging trays were cracked. This may compromise the sterility barrier. If used, the potential affect to the patient may be infection.

Soft Tip Introducing Sheath Boston Scientific Microvasive 2009-01-19 2008-12-31 45865 Type II 5660, 5661, 5661ST, 5662, 5662ST, 5663, 5663ST, 5665, 5665ST, 5667ST, 5670, 5670ST, 5671, 5672ST, 5675ST, 5676, 5676ST, 5890ST

> 50 Numbers, Contact Mfr. The sheath's radiographic tip marker band may become dislodged or detached from the sheath during an interventional procedure posing an embolic risk to the patient.

Ximatron Digital Imaging 7.5.51 SP2Updated recall # 41318 previously posted on 2008-03-31.

Varian Medical Systems, Inc. 2009-01-19 2007-06-25 41318 Type I 7.5.51 SP2, H72 H720702 A software code malfunction has been identified in Ximavision / Ximatron digital imaging v7.5.51.6 sp2. This only affects systems using the Ximatron simulator. Other simulators (eg. Acuity) are not affected.

Easydiagnost Eleva Philips Medical Systems DMC GMBH 2009-02-02 2009-01-12 45982 Type II 9890 010 03631 N/A Patient images can be mixed up during viewing and printing. Images of one patient might be stored in the folder of another patient. This can be full images but also part images of two patients on one image.

Modular Femoral Neck Encore Medical, L.P. 2009-02-02 2008-05-27 44847 Type II N/A 53872833 During routine in-house testing a visual discrepancy was found. The visual non-conformance consisted of a scallop feature with twice as many lobes, 24 instead of 12.

BiPAP Focus Ventilator Power Cord Respironics California, Inc. 2009-02-02 2008-09-24 45154 Type II 1033869 Manufactured bef.Mar.27/ 08 This corrective action is being taken to address power supply failures on some ventilators. The failures are a result of transient power surges created from disconnection or intermittent electrical connection.

A) Advia Centaur System-HIV Enhanced AssayB) Advia Centaur XP System-HIV Enhanced Assay

Siemens Healthcare Diagnostics Inc. 2009-02-02 2009-01-08 45980 Type III A) 01463908B) 01463908

A) 16384031, 19633033, 28655040, 27767040, 19004033, 30279040, 28082040, 27281040B) 19633033, 28655040, 16384031, 19004033, 30279040, 28082040, 20234033

Investigation showed some reagent lots exhibited a loss in type O sensitivity which could potentially result in a missed detection of a HIV type O infection specifically during seroconversion.

Staphaurex Plus 150/450 Remel Europe Ltd. 2009-02-02 2008-12-03 45985 Type II RE30950102, RE30950201 J311610, J311510 Potential for false positive reactions with some strains of staphylococcus epidermidis which may result in misidentification as staphylococcus aureus.

BD Integra 1mlTB Syringe Becton Dickinson And Company 2009-02-02 2008-12-01 45355 Type III 305298 8078251 There was a typo error on the label of the 100 unit shelf carton. The expiry date on this label reads 2013-13 when it should read 2013-03 (designating March 2013).

Ransel Kit Randox Laboratories Ltd. 2009-02-02 2008-12-22 45734 Type III HG1539, RS504, RS505 138702, 122999, 100558, 084225, 098485, 083256, 101130

Instructions for preparation of the HG 1539 reagent, required if using human blood samples for application to Ransel Kit, RS 504/ RS 505, are incorrect. The current dilution of 1 + 24 is incorrect, it should be 1 + 4.

Simulfluor Flu A/B Immunofluor Assay Millipore Corporation Bioscience Division 2009-02-02 2008-11-21 45681 Type II 3121, 5250 >10 numbers, Contact Mfr. Millipore confirmed that specific lots of SimulFluor Flu A/B reagent may cross react with respiratory syncytial virus, potentially leading to a misdiagnosis of influenza B, thus a recall was issued.

Gendex GXCB-500 Cone Beam 3-D Imaging Imaging Sciences International, Inc. 2009-02-02 2009-01-08 45997 Type II G1-15-1-0 NU010286 The phantom used for calibration of the Gendex GXCB-500 Cone Beam 3-D imaging machine is incorrect and can result in providing inaccurate measurements within the software program.

Urovysion Bladder DNA Probe Kit Abbott Molecular Inc. 2009-02-02 2009-01-04 45862 Type III 36-161070 N/A The device is registered as a class II, however it has been shipped with an intended use claim that was not approved and which causes the device to be considered a class III.

Terumo Advanced Perfusion System 1 Terumo Cardiovascular Systems Corp. 2009-02-02 2009-01-23 46050 Type II 801763 0013, 0017, 0020, 0021, 0144, 0193, 0396, 0601 The screws in the power MGR board may come loose and come into contact with system 1 chassis, causing a short circuit between the board and the chassis.

Bioplex 2200 Detector Calibration Packs Bio-Rad Laboratories Diagnostics Group 2009-02-02 2008-12-01 45218 Type II 660-0000 950413 Detector calibration packs from lot number 950413 may calibrate the Bioplex 2200 detector module incorrectly leading to the possibility of low count errors for patient samples, assay calibrators, QC material.

A) Liquicheck Cardiac Markers Control LT - TrilevelB) Liquicheck Cardiac Markers Control LT - Level 1C) Liquicheck Cardiac Markers Control LT - Level 2D) Liquicheck Cardiac Markers Control LT - Level 3E) Liquicheck Cardiac Markers Control LT - Trilevel Minipak

Bio-Rad Laboratories 2009-02-02 2008-11-28 45219 Type II A) 145B) 146C) 147D) 148E) 145X

A) 23430, 23440B) 23431, 23441C) 23432, 23442D) 23433, 23443E) 23430, 23440

NT-proBNP and Troponine I do not meet the 20 day open vial claim. Package insert have been revised to indicate that NT-proBNP will be stable for 10 days and Troponine I will be stable for 8 days at 2-8 c.

Carina Home Ventilator Draeger Medical B.V. 2009-02-02 2009-01-14 46109 Type II 5703700 Version 1.1-2.4 No device alarm when pilot line gets disconnected.Minute Lab PSA Semi-Quantitative Test Tremblay Harrison Inc. 2009-02-02 2008-09-19 46147 Type II PSD-A1, PSS-A1 PSA 6090007, PSA 6090008 Current product is unable to meet performance requirements which may yield false negative

prostate specific antigen results at or near the limit of detection. A) Achieva 3.0T MRI System-Main UnitB) Achieva 1.5T MRI System-Main UnitC) Achieva XR MRI System-Main UnitD) Intera 1.5T MRI SystemE) Intera 3.0T MRI System-Main Unit

Philips Medical Systems Nederland B.V. 2009-02-02 2008-09-26 44066 Type II A) Achieva 3.0TB) Achieva 1.5TC) Achieva XRD) Intera 1.5TE) Intera 3.0T

A) N/AB) N/AC) N/AD) N/AE) N/A

Lithium polymer battery for the VCG sensor may fail after being physically dropped from a height (i.e.1 metre). The failed battery may produce a flame or emit smoke. The failure may occur instantly or delayed.

A) Voluson E8 Ultrasound SystemB) Voluson E8 Expert Ultrasound System

GE Medical Systems Kretztechnik GMBH & CO OHG 2009-02-02 2008-04-01 42409 Type III A) N/AB) N/A

A) >10 numbers, Contact Mfr.B) D03347, D03345, D03655

When focal zoom is activated and M-mode is on, performance measurements on M-mode trace may not be accurate. When sonographer unfreezes the image and freezes again, measurements may or may not be accurate.

Giraffe Omnibed Ohmeda Medical, A Division Of Datex Ohmeda Inc. 2009-02-02 2008-07-31 43008 Type II Omnibed >10 numbers, Contact Mfr. There is an accumulation of debris and discolouration on component assemblies of the device, emphasizing the canopy seal area.

Rear Case Assembly For Auto Syringe Baxter Healthcare Corporation 2009-02-02 2008-09-19 43803 Type II 1M8560R AAS5001530RP, AAS5001531RP The ESD grounding squares were incorrectly placed on an AS50 rear case assembly. The conductive copper side instead of the kapton side was incorrectly facing the I/O printed circuit board assembly.

Durepair Dura Regeneration Matrix Medtronic Inc. 2009-02-02 2008-11-17 45672 Type II 61100, 61103, 61105, 61106, 61107, 61110, 61111, 61113, 61151, 61152, 62105, 62110

All Lots Preliminary data suggests that the foreign body reaction of concomitant use of some ancillary products with Durepair is more pronounced than Durepair alone and may increase rates of other known risks.

Galileo Echo Blood Bank Analyzer Immucor Inc. 2009-02-02 2008-11-21 45821 Type II N/A M00265 With the implementation of version 1.1.2.28, Immucor discovered when a clot was detected, the probe moved to the rinse station before the operator responded to the user prompt whether the probe was clean.

Prosolv Cardiovascular Image and Information Management

Problem Solving Concepts, Inc. 2009-02-02 2008-10-24 46106 Type II PROSOLV CARDIOVASCULAR CL , PROSOLV CARDIOVASCULAR SE

VERSIONS 3.5.1776, 3.5.1530, 4.0.1.142, 3.5.43, 3.0.48

A software defect was detected with its cardiology pacs software when exporting a patient's diagnostic images to a CD.

A) Innova 2100/2100 IQ Digital MonitoringB) Innova 4100 IQ

GE Healthcare 2009-02-16 2008-06-18 42702 Type II A) S18751AM, S18751APB) S18391MD

A) S/N's 1203100025, 452849BU3, 112436VE1, 452927BU7, 524113BU8B) S/N's 1203/00034, 1203/00030, 604/20097, 460566BU3, 112438VE7, 469393BU3

The LCD monitor support may disengage from its arm and fall on the table. Incorrect cable routing may cause the ECG monitor power cable to be damaged, potential for short circuit, sparks & electric shock.

A) Evita 4B) Evita 2 DuraC) Evita XL

Draeger Medical AG & CO. KG 2009-02-16 2008-06-23 42978 Type II A) 8306611, 8412980B) 8306611, 8411800C) 8306611, 84119600-XX

A) ARXM-0005B) ARYB-0067C) ARYB-0044X

The power failure alarm generator sporadically emits signal at a high, barely perceptible, frequency. Affects only units in which the replacement CO2 carrier PCB installed between 2005 and 2008 during a repair.

A) Securefit Hip Stem - 132 degreeB) Securefit Hip Stem - 127 degreeC) Solar Shoulder - Humeral ComponentD) Osteonics Omnifit Hip Stem

Howmedica Osteonics Corporation 2009-02-16 2008-09-22 44184 Type II A) 6051-0830S, 6051-0935S, 6051-1140SB) 6054-0812S, 6054-1014SC) 5351-4108D) 6070-0730A, 6070-0830A

A) 901MME, EN1MME, J41MLE, 4PMMMEB) AKKMME, 72MMMEC) VV4MKED) VK0MME, D9VMME, RHWMME

Voids of various size were found in the seal area of a series of blisters processed on a specific heat sealer. They are related to a progressive scratch on the heat plate that caused the voids in some packaging.

Access Immunoassay Systems Inhibin A Beckman Coulter Inc. 2009-02-16 2008-10-15 44413 Type III A36097 N/A The Inhibin A certificate of analysis has the incorrect unit of measure listed as iu/ml. The correct unit of measure is pg/ml.

Innova 2121 IQ GE Healthcare 2009-02-16 2008-11-18 45109 Type III S18821AM S/N 554413BU5 1) Intermittent failure associated with the function used to store images. 2) Software failure on the function used to send images for storage on the hard disk.

Vibe Machine Vibe Technologies 2009-02-16 2008-12-26 45192 Type III N/A N/A Company did not obtain marketing approval before offering vibe machine for sale...product is a device because it is intended for use in diagnosis of disease or in cure, treatment, or prevention of disease.

TD-Synergy Software (TD-SYN-01) Technidata S.A.S. 2009-02-16 2008-12-11 45827 Type II N/A N/A In certain circumstances, a patient number could be erased and replaced with the patient's hospitalization number. This defect could lead to a patient identification mismatch.

A) Osteonics Omnifit M-HA Hip StemB) Accolade TMZF Press Fit Stem 132 DegreeC) Accolade TMZF Press Fit Stem 127 Degree

Howmedica Osteonics - Stryker Ireland 2009-02-16 2009-01-06 45981 Type II A) 6041-0730, 6041-0830, 6041-0935, 6041-1035, 6041-1140B) 6020-0130, 6020-0230, 6020-0335, 6020-0435, 6020-0537, 6020-0637, 6020-2530, 6020-3535, 6020-4535, 6020-5537C) 6021-0130, 6021-0230, 6021-0335, 6021-0435, 6021-0537, 6021-2530, 6021-3535, 6021-4535, 6021-5537

A) > 10 Numbers, Contact Mfr. B) > 10 Numbers, Contact Mfr.C) > 10 Numbers, Contact Mfr.

Specified lots of sprayed HA stems produced did not meet Stryker's internal material specification for tensile bond strength and crystallinity.

A) HLA Typing TraysB) HLA Typing Trays - B-27C) HLA Typing Trays - Class II

GTI, Inc. 2009-02-16 2009-01-12 46071 Type III A) GTI-72C, GTI-72L, GTI-72ORB) GTI-B27C) GTI-DR

A) 32.5, 32.6, 32.7, 10.3, 10.7B) 16.2C) 55.0

Reactivity of HLA Typing Trays has changed since the products were released. At the time of release, product met the specifications for reactivity, but upon storage and shipment, reactivity has declined.

such as infants.

A) Axiom Artis DBAB) Axiom Artis DTAC) Axiom Artis DMPD) Axiom Artis DBCE) Artis Zee Multi-PurposeF) Artis Zee CeilingG) Artis Zee BiplaneH) Axiom Artis FCI) Axiom Artis DFCJ) Axiom Artis DFCK) Axiom Artis FAL) Axiom Artis MPM) Axiom Artis BCN) Axiom Artis BAO) Axiom Artis TA

Siemens AG 2009-02-16 2008-08-06 43374 Type II A) 7555357B) 7008605C) 7555365D) 59 17 054E) 10094139F) 10094137G) 10094141, 7728392H) 59 04 433I) 7727717J) 7412807K) 5904441L) 5904466M) 5904649N) 5904656O) 7007755

A) 53069, 53081, 53088, 53097, 53101B) 55127, 55140, 55142, 55143, 55144, 55145, 55168, 55197, 55203, 55209, 55236, 55257, 55303, 55402, 55433, 55080, 55437, 55092, 55119, 55122C) 57017, 57026, 57030, 57047, 57052, 57064, 57068, 57119, 57123, 57160 D) 49003E) 157105F) 146106G) 153146, 153163, 44212, 44217, 44274, 44102, H) 10037, 10311, 10376I) 40033J) 35051, 35177, 35749, 35195, 35216, 35219, 35298, 35391, 35417, 35531K) 25006, 25055, 25076, 25147L) 20002, 20018, 20039, 20069, 20070, 20151, 20163, 20215M) 14026, 14041, 14054, 14080N) 28016, 28022, 28048, 28064, 28069, 28072

A customer safety advisory notice was issued to notify customers about important instructions regarding patient safety on the Artis system.

A) AMX 4 Mobile X-ray SystemB) AMX-4+ Mobile X-ray System

GE Healthcare 2009-02-16 2008-10-03 44190 Type II A) 2115090, 46-270157G-1B) 2275938-7

O) 32070A) S/N'S 280105WK8, 311216WK6, 263322WK0, 219252WK4, 467148WK3

Battery sensor board was not insulated. Metal objects could fall on the board during servicing of the systems that may result in sparks.

2.0mm Stainless Steel Crimp Sleeve Biomet Orthopedics, Inc. 2009-02-16 2008-09-24 44279 Type II 350805B) S/N 966367WK5S/N 568400 Outer box labelled as a 2.0mm crimp sleeve may contain an alternate label on the inner

A) Sterile ECLS PackB) Sterile Lap Chole PackC) Sterile Lap Chole PackD) Ens. Strl. Pour SternotomieE) Sterile Major Laparoscopic PackF) Ens. Pour EndocholecystectomieG) Ens. Pontage Femora-PopliteH) Sterile Emergency Chest PackI) Sterile Aneurysm PackJ) Strl. Radical Prostatectomy PackK) Sterile Nephrectomy PackL) Sterile Craniotomy PackM) Sterile Mastectomy Vic PackN) Oto-Rhino-Laringologie MineureO) Strl. Ambulatory Minor Vacular PackP) Sterile AAA Victoria PackQ) Ens. Pontageaorto BifemoralR) Ens. Strl Chirurgie De L'AorteS) Sterile AV Fistula PackT) Sterile Major Abdominal Pack

Cardinal Health 2009-02-16 2008-09-22 44332 Type II A) SCV30CBXXXB) SLC30LCXXXC) SCV30AAXXXD) SCV30STXXX, SCV30THXXXE) SBA30MLXXXF) SBA30ENXXXG) SCV30FPXXA, SCV30FPXXXH) SBA30THXXXI) SBA30THXXXJ) SOT30RPXXXK) SBA30NPXXXL) SNE30CNXXX, SNE30CRXXXM) SBA30MYXXXN) SBA30ELXXX, SBA30LBXXX, SBA30MNXXX, SBA30OL'XXX', SLC30LAXXX, SLC30LCXXX, SLC30LPXXXO) SBA30MVRHAP) SBA30AAXXX, SCV30AOXXXQ) SCV30ABXXX, SCV30ACXXXR) SCV30CEXXX, SCV30CVXXX, SCV30EAXXXS) SCV30AF'XXX'T) SBA30MAXXX

A) 813434, 820299, 827471, 829163, 858988B) > 10 Numbers, Contact Mfr.C) > 10 Numbers, Contact Mfr.D) 826939, 835300, 838978, 844676, 853786, 817677, 824596, 834460, 841029, 846104, 851508, 855864E) 819184, 826942, 839638, 844698, 847088, 851615 F) > 10 Numbers, Contact Mfr.G) > 10 Numbers, Contact Mfr.H) > 10 Numbers, Contact Mfr.I) 757212, 773368, 788682, 791871, 793268, 826324, 831416, 843528, 847389, 852782J) > 10 Numbers, Contact Mfr.K) 746846, 758604, 776580, 796554, 805480, 814976, 845580, 852840L) > 10 Numbers, Contact Mfr.M) 857254N) > 10 Numbers, Contact Mfr.O) > 10 Numbers, Contact Mfr.P) > 10 Numbers, Contact Mfr.Q) > 10 Numbers, Contact Mfr.R) > 10 Numbers, Contact Mfr.S) 757636, 764645, 784768, 797005, 809371, 824689, 834298, 842836, 848983, 855432

packaging.Customs kits manufactured by Source Medical contain titanium clips being recalled by Teleflex Medical.

A) OEC Mobile Elite C-Arms Gen. PlatformB) OEC Mobile Elite C-Arms Cooling

GE OEC Medical Systems Inc. 2009-02-16 2008-09-25 44335 Type II A) S2024DTB) S2024EH

T) 753435, 765517, 787942A) S/N E9-0148B) S/N 7019-CMH

The device may not conform to Federal regulations for proper beam alignment and overlap requirements in the mag 1 or mag 2 X-ray mode for systems manufactured on or after June

Wizard Low Profile Gastrostomy Device Bard Access Systems, Inc. 2009-02-16 2008-10-09 44381 Type II 00200W, 00201W, 00202W, 00203W, 00204W, 00205W, 00206W, 00207W, 00210W, 00212W, 00213W, 00214W, 00215W, 00216W, 00217W, 00218W, 00221W, 00222W, 00223W, 00224W,

> 100 Numbers, Contact Mfr.10, 2006. Leaflet fractures, which could cause leakage from the device of gastric contents and feeding solutions.

A) Advia Centaur XP Siemens Healthcare Diagnostics Inc. 2009-02-16 2008-10-14 44404 Type III00225WA) 04385983, 129501 A) 138 A low bias between serum and the plasma samples is greater on reagent lot 138 when

B) Advia CentaurOxylog 3000 Ventilator Draeger Medical B.V. 2009-02-16 2008-10-22 44596 Type II

B) 04385983, 1295012M86955

B) 138SRYB-0074, SRYB-0132

compared to other lots. Ventilating in bipap mode with the pressure rise time set to the highest setting and the expiration time being exactly 0.5 seconds which will lead to inspiration phase stopping and

Diamond Mammography X-ray Equipment GE Healthcare 2009-02-16 2008-10-09 44731 Type II 81000 S/N'S 20572 & 20693ventilation will resume in 5 seconds.Screws holding the rails on the easy compression system (ECS) assembly were not appropriately tightened and could create a potential hazardous situation if the C-arms were

Centricity QS Perinatal System GE Healthcare Integrated IT Solutions 2009-02-16 2008-10-02 45092 Type II 2033579-008 S/N'S J4RR1420F, L4RR1515Fto fall. The in, out & net fluid totals values will not honour the numeric precision configuration, which will display a whole number, losing decimal point accuracy for low weight patients

to firm's explicit specifications.

A) Gemini GXL 6/10/16 Slice PET/CT SystemB) Gemini TF 16 PET/CT System

Philips Medical Systems (Cleveland), Inc. 2009-02-16 2009-01-16 46137 Type II A) 4535 673 04201B) 4535 673 89331

A) N/AB) N/A

The transducer used for pulmonary gating kit of the CT subsystem relays inaccurate signals in the bellows system. This could result in an image being displayed with an incorrect phase

C) Gemini TF 64 PET/CT SystemA) Advantage Workstation Version 4.2B) AW VolumeshareC) AW Volumeshare 2

GE Healthcare 2009-02-16 2008-04-04 42738 Type IIC) 4550 110 09021A) 2378698-2, B77001ST, B78001ME, B79991EP, B79991SSB) B79991SSC) 2378698-2, 5142883, 5173500, 5174073, 5183998, B77121VB,

C) N/AA) > 10 Numbers, Contact Mfr.B) 62426G, 62427G, 14513A, 59993G, 69491G, 63624GC) > 10 Numbers, Contact Mfr.

of the respiratory cycle. AW version 4.2, AW Volumeshare (4.3) & AW Volumeshare 2(4.4): the software incorrectly reloads a save state/save tracking & display incorrect vessel name over restored images. Mismatch of vessel labels.

Floseal Endoscopic Applicator Baxter Healthcare Corporation 2009-02-16 2008-08-06 43320 Type IIB79831SR, H25801BP, P51801BP1500181 07E025, 07F012, 08A027 There was a presence of a dark discolouration of the Floseal material as it was pushed

Aisys Anesthesia Carestation Datex-Ohmeda, Inc. 2009-02-16 2008-10-15 43371 Type III 1011-8302-000 > 10 Numbers, Contact Mfr.through the sleeve.The back pressure and inflow check valves may leak. The cassette interface board fails to establish communications with other devices and losing the electronic agent level indicator with no alarms given.

Duralite Pyramid Receiver Proximal AdaptorA) Easy Core Biopsy SystemB) Easy Core Biopsy Needle - Delta Notch

The Ohio Willow Wood CompanyBoston Scientific Corporation

2009-02-162009-02-16

2008-09-112008-10-24

4416544614

Type IIType III

FND-136102A) M001434561, M001434571, M001434581, M001434591, M001434601B) M001434501, M001434511, M001434521, M001434531, M001434541

N/AA) 11524979, 11546134, 11516921, 11550539, 11518343, 11535832, 11634771, 11520769B) 11524375, 11535831, 11532167, 11554902, 11516922, 11532173, 11547760, 11569929, 11520532, 11539484, 11579252, 11642796,

In-house long term testing has indicated the adapter may crack in extreme situations.Difficulty cocking or arming the cannula latch on the device. This difficulty may result in an inability to use the device. Investigation shows that is related to specific manufactured lots.

Synfix LR, Low Profile U-Joint Driver Synthes (Canada) Ltd. 2009-02-16 2009-01-19 46154 Type II 03.802.23111520676, 11551300 N/A Complaints received for distal tip breakage of the Synfix LR, Low Profile U-Joint Driver with

Artiste MV Siemens Medical Solutions USA, Inc. Oncology Care Systems 2009-02-16 2009-01-22 46187 Type II 8139789 S/N 5414instances of the tips remaining in the patients.On inserting the accessory, the IL26 accessory insertion interlock indication may disappear from the monitor even if the accessory is not locked in accessory holder preventing gantry

Miltex Stainless Steel Surgical Blades Miltex, Inc. 2009-02-16 2008-11-17 46242 Type II 4-312B S07C06and collimator motion. The blades appear to have an excessive taper at the tip of the blade and may break during

3160 MRI Sytem-Power Battery Components Invivo Corporation 2009-02-16 2008-08-13 46281 Type II 9065 Date Codes 2808 And Loweruse. The lithium polymer battery may fail after being physically dropped from a height. Failed battery may momentarily produce a flame and then emit smoke. The failure may occur

Signa 3.0T Excite HD - Magnet GE Healthcare 2009-02-16 2008-04-04 41528 Type II N/A N/Ainstantly or after short period. When using PROPELLER T2 FLAIR application on 3T HD systems the surface coil intensity correction image enhancement option made Hippocampus brighter than images taken with

Ponsky Non-Balloon Gastrostomy Tube Bard Access Systems, Inc. 2009-02-16 2008-05-16 42263 Type II 000630, 000631 HURJ0589, HURJ1533, HURE3333, the SCIC option off.Dome develops a tear during device stretch & distention with an obturator or the obturator

A) Capture-CMV Indicator Red Cells Immucor Inc. 2009-02-16 2008-12-15 45761 Type III A) 0066238HURG1431, HURJ0568A) 228083

may slip out of the pocket during placement.All vials within the product lot have been printed with the same serial number.

B) Capture-S Indicator Red CellsFuji Synapse Image & Information System Fuji Film Medical Systems USA, Inc. 2009-02-16 2008-12-18 46160 Type III

B) 0006428N/A

B) 221299N/A When scrolling through the images of a series, the scrolling appears choppy, hesitates,

Unicel DXC 880I Synchron Access Clinical System Beckman Coulter Inc. 2009-02-16 2009-01-21 46185 Type II A59102, A59126 0205, 0206jumps ahead and is not smooth. There is potential to have incorrect patient information associated with results on the DxI

Precision Spinal Cord Stimulation System Boston Scientific Neuromodulation Corporation 2009-02-16 2008-09-26 44523 Type II SC-5300 7392, 7455, 8015, 8731, 8768, 10686, 10949, console and DxI printed reports when the DxC database is renewed. Reports of charger 1.0 burns have been reported. Burns occurred in the area of charging

A) Axis Variable-Angle Dual-Detector GammaB) Irix Triple Detector Camera

Philips Medical Systems (Cleveland), Inc. 2009-02-16 2008-10-14 46012 Type II A) N211037, N211039B) N211038, N211040

11625, 12198, 8733, 11460, 11724A) N/AB) N/A

while using the charger 1.0. Devices may overheat (that have the active shunt module retrofit) resulting in the appearance of smoke, a burning smell, and an e-stop condition. This will disable the system

CGMS IPRO System - Solutions Software Medtronic Minimed 2009-02-16 2009-01-12 46194 Type III MMT-7319 N/Arotate motion and all other motions.There is an error in Solutions Software for iPRO (model MMT-7319 version 2.1A) when the program is set to display blood glucose values in mmol/litre and they are exported for use in

Ceiling Tube Mount With Column Extensions DEL Medical Imaging Corporation 2009-02-16 2009-01-26 46273 Type II CTM/DCTM Contact Mfr.another program. If the retaining ring inside the column assembly is not inspected and replaced when worn or loose there is the potential for the supporting cable to become detached from the column

Steerocath Steerable Catheter Non Temperature Boston Scientific Microvasive 2009-02-16 2008-02-20 46322 Type III 2028BL 0011043537, 0011049772, 0011059410, 0011069509, 0011078605

causing the column to fall. Boston Scientific identified, through internal testing of the product a potential of a breach to the sterile barrier. Specifically, the package seal may degrade after sterilization.

Patient On-Line Fresenius AG 2009-02-16 2008-04-06 41821 Type II N/A Software Version 4.201 Cat.# 2850101 There is a software code error, which could result in inaccurate calculations and displays of

A) 3.0T Signa HDX MR System - Main Unit GE Healthcare 2009-02-16 2008-05-23 42811 Type II A) M3335JM A) S/N#S 251168MR1, 7831GQ1, 1078GQ5the group peritonitis rate. When the zoom mode is used for breast imaging, there is a spatial distortion that can be

B) 1.5T Signa HDX MR System - Main UnitA) Uroview 2800 System - Urological TableB) OEC Miniview 6800 Digital Mobile UnitC) OEC Flexview 8800 Standard C-ArmD) OEC 9800 Plus Mobile Digital System

GE OEC Medical Systems Inc. 2009-02-16 2008-04-25 42976 Type IIB) M3335JB, M3335JGA) 00-870638-02B) 00-870637-02C) 2350023D) 00-870632-05, 2274023

B) > 10 Numbers, Contact Mfr.A) P6-0404-R, P6-0396-L, P6-0528-R, P6-0390-R, P4-0433-R, P4-0376-R, P4-0400-RB) > 10 Numbers, Contact Mfr.C) N/A

seen on 3D lateral images.Ground path on the workstation mounting bracket is suspect. Single fault conditions exist that could energize the mounting bracket, resulting in a noncompliance with regulatory requirements.

Modular Microplasty Cup Inserter Biomet, Inc. 2009-02-16 2008-07-28 43310 Type II N/AD) > 10 Numbers, Contact Mfr.97525 The pin and clip may fracture during surgery. Affected lots were found to be non-conforming

size 2 and size 4, for the specified lots.

Centricity PACS Workstation Software GE Healthcare Integrated IT Solutions 2009-02-16 2008-11-17 43840 Type II 2023617-XXX, K2004W, K2004Z, K2006WB, K2006WC, K2006WD, K2006WE, K2006WF, K2006WG, K2006WH, K2006WJ, K2022PD, K2022PE, K2022PF, K2022PG, K2022PH, K2022PJ, K2022SA, K2022SB, K2022SC, K2022SD, K2022SE, K2022SF, K2030JN, K2030MR, K2033JF, K2033L, K2033LB, K2033LC, K2033LE, K2033LG, K2033SE, K2033SF, K2070L, P0001KA,

> 100 Numbers, Contact Mfr. If DDP configured to place current & historical studies in different regions than system default, user may think old study is new one. Patient jacket content may mis-match image displayed.

A) Solar 8000I System - Patient MonitorB) Patient Data Module

GE Healthcare 2009-02-16 2008-08-26 43880 Type IIP0001KCA) SLR8KI-XXX-XXX-XXX-XXXB) PDM-XXX-XXX-XXXX

A) N/AB) N/A

Loss of monitoring at Solar 8000i for approx. 1-2 minutes as a result of unexpected reset of Solar 8000i monitor. Problem occurred when solar 8000i, patient data module and

Datex-Ohmeda Network Aand Icentral GE Healthcare Findland OY 2009-02-16 2008-12-17 44822 Type II M1113714, M1113715 > 10 Numbers, Contact Mfr.telemetry used in combo mode. ICentral does not provide audio or visual alarms for: 1) AFIB, VT>2 & PVC(1) when used with ApexPro, 2)VT>2 & PVC(1) when used with solar, dash or eagle (cardiac package

A) Immulite 2000 System-Analyzer Class IIIB) Immulite 2000 System-Analyzer Class IIC) Immulite 2000-Instrument Class IV

Siemens Healthcare Diagnostics Inc. 2009-02-16 2009-01-22 46193 Type II A) 030002-03B) 030002-03C) 030002-03

A) F0813B) F0813C) C0181R

software only). An investigation revealed that the digital fluidics PC board (PN 450116-002) contains an engineering design flaw (a missing jumper) which affects samples diluted on board. / Une enquête a révélé que la carte de circuits imprimés de logique fluidique (numéro de pièce 450116-002) comporte un défaut de conception technique (cavalier manquant) qui concerne

Bremer Halo Mayfield Adapter Depuy Spine 2009-02-16 2009-01-30 46344 Type III AC003 055561, 055562la dilution d’échantillon par la carte électronique.There is a missing thread feature on both components of the device (the anterior and posterior adapters) that would make the unit unusable because it will not attach to the

Sterrad 50 Sterilizer Advanced Sterilization Products, A Division Of Ethicon

2009-02-16 2009-01-13 46352 Type II 10050 > 10 Numbers, Contact Mfr.Mayfield swivel adapter.There is a remote circumstance that could cause a capacitor in the vacuum pump component of the system to overheat and potentially create a hazardous condition inside the

Philips Bougie Coloplast A/S 2009-02-16 2009-01-23 46373 Type II AG55XX All Manufactured Between 2003-2008system, resulting in smoke and/or fire.One vigilance case & 2 complaints were received in 2008 in relation to the Philips catheter, 1 eye, female metric thread. The metallic tip detached from the shaft upon or prior to using

Stille Sonestra 6210 Fluoroscopy Table Stille AB 2009-02-16 2008-08-27 44642 Type II N/A N/Athe device. A short circuit may lead to a malfunction in the control box. This can result in an uncontrolled movement of the table which cannot be stopped by disconnecting the device

Oxoid Fraser Broth Base Oxoid Limited 2009-02-16 2008-08-18 45182 Type II CM0895B 649795, 667911, 649794, 667910, 662546from the main power supply. Labelling error. Portuguese instructions for preparation indicate to add 12.9g of CM0895 to

A) Variant II System with CDM 3.5 softwareB) Variant II Turbo with CDM 3.6T System

Bio-Rad Laboratories Diagnostics Group 2009-02-16 2009-02-02 46347 Type I A) N/AB) N/A

A) N/AB) N/A

one litre of water. Correct amount of water should be 225ml.Bio-Rad recommends to carefully review the summary report for duplicate tube position numbers or barcode ID within the same rack. Such duplication could potentially lead to

Elekta Precise Treatment Table Elekta Limited 2009-02-16 2009-01-23 46393 Type II MRT 5071, MRT 5111, MRT 5121 NEBATO 124001 TO 124515, CHINA 125001 TO 126001, Hexapod ready 133801 to 133860,

discrepant sample results.An issue has been identified that in desktop pro release 6.1, 6.2 and 7.0 sites with precise table, there is a possible error (of up to 8mm) in the reported table longitudinal position.

Unisplint, Maxillofacial Fracture Kin Walter Lorenz Surgical, Inc. Also Trading As:Biomet Microfixation

2009-02-16 2008-11-08 45053 Type III 01-1100Axesse NPSS 133801 to 133860040712, 060622, 522267 The outer label of the Unisplint rubber bands (part of Maxillofacial Fracture Kit) indicated

natural rubber latex while the inner label indicated latex free. The inner label is the correct

Vitros DT Calibrator Kit Ortho-Clinical Diagnostics Inc. 2009-03-02 2009-02-03 46501 Type III 1957927 25 And Abovelabel.The calibrator kit storage and stability conditions require an update for lots 25 and above. The calibrator response may be lower than expected for alkaline phosphates for

Logiciel TDHisto/Cyto Software Technidata S.A.S. 2009-03-02 2008-10-11 44729 Type II N/A N/Aconcentrations above 400 u/l. A user working in TDHC who launches the "work in progress" function is attributed the rights

A) Engstrom Carestation Datex-Ohmeda, Inc. 2009-03-02 2008-02-12 40775 Type II A) 1505-9000-000 A) > 10 Numbers, Contact Mfr.of another user.Dual fault failure mode of Engstrom system may occur that can cause patient airway

B) Engstrom Carestation - Trolley OptionsAquarius System Edwards Lifesciences LLC 2009-03-02 2008-12-01 45544 Type II

B) 1505-8538-000GEF09700

B) > 10 Numbers, Contact Mfr.> 10 Numbers, Contact Mfr.

pressures to exceed the user settable PMAX limit.1) Operating manual incorrectly depicts the connection of the filtrate line & filter, for machine operation in the hemofiltration mode. 2) Deviations in the total fluid loss (TFL)

Minimally Invasive Solutions Technology Offset Rasp Zimmer Inc. 2009-03-02 2008-12-31 46270 Type II 00-7806-035-01, 00-7806-035-02 > 10 Numbers, Contact Mfr.balance alarm. There is potential of the C-clip located near the connection end could fracture or fall off the

HandlesCoCr Head 0 32/+4L Taper 12/14 Zimmer GMBH 2009-03-02 2009-01-22 46271 Type III 14.32.07-20 2405362

device and into the wound.Some units from this lot may not be etched with the item number and lot number on the rim.

Aquilion One Toshiba Medical Systems Corporation 2009-03-02 2009-01-27 46272 Type II TSX-301A/2 N/A The surestart function may not operate normally and the exam plan may be interrupted or

A) Coonrad-Morrey Total Elbow - HumeralB) Coonrad-Morrey Total Elbow - Ulnar

Zimmer Inc. 2009-03-02 2009-02-06 46533 Type II A) 32-8105-027-04, 32-8105-027-06B) 32-8105-043-01, 32-8105-043-02, 32-

A) N/AB) N/A

the scan start timing of the actual scan may be delayed as a result.Review of the current surgical technique was initiated relative to canal preparation for the extra-small humeral component. It was determined that the instruction provided could be

Abbott Prism HBsAg Abbott GMBH & Co. K.G. 2009-03-02 2009-02-06 46534 Type III8105-093-01, 32-8105-093-023A47-48 68761HN00

misinterpreted.There is an increase in frequency of drain time errors (3X223, 3X224, 3X225) leading to results not being generated when testing some patient samples with lot number 68761HN00.

9-10mm Ezloc Femoral Fixation Device Biomet Sports Medicine, Inc. 2009-03-02 2008-09-18 44280 Type II 904781 164080 Product labelled as 9-10mm Ezloc Femoral Fixation "standard length" actually contained

Triathlon Primary Cemented Baseplate Howmedica Osteonics Corporation 2009-03-02 2009-01-23 46208 Type II 5520-B-400 J5119SH8NT"long length". There was a cross mix between two batches of Triathlon Primary Cemented Baseplates,

the lowest acceptable limit.

Triathlon Primary Cemented Baseplate Howmedica Osteonics Corporation 2009-03-02 2009-01-29 46302 Type II 5520-B-200 SJE3F There was a cross mix between two batches of Triathlon Primary Cemented Baseplates,

Octeia 25-Hydroxy Vitamin D Kit Immunodiagnostic Systems Ltd. 2009-03-02 2009-02-02 46543 Type III AC-57F1 62729size 2 and size 4, for the specified lots.During internal testing, low absorbance values were observed when using kits from this batch.

Vasoview 6 Endoscopic Vessel Harvesting Maquet Cardiovascular LLC 2009-03-02 2009-02-06 46544 Type II VH-2000 8090272, 8090571, 8110571, 8100771, 8070771Investigation has shown the cause of the low absorbance values to be the biotin buffer.During a routine shelf-life aging test, a small number of devices exhibited signs of damaged

Heartstring II Proximal Seal System Maquet Cardiovascular LLC 2009-03-02 2009-02-09 46546 Type I HSK-2038, HSK-2043 8120271, 8101072packaging, which may lead to compromised sterility. During a routine shelf-life aging test, a number of devices exhibited signs of damaged packaging, which may lead to compromised sterility which has 30% chance of death as the

Fastrac "Pull" Gastric Access Port Kit Bard Access Systems, Inc. 2009-03-02 2008-12-23 45860 Type II 5729 > 10 Numbers, Contact Mfr.contamination is on the bloodstream. Looped portion of the grasping snare may detach from the crimp and remain in the patient

Focal Software CD Computerized Medical Systems 2009-03-02 2009-02-06 46521 Type II N/A Release 4.1.1 & Higherduring the guidewire grasping and replacement process. Once individual MLC leaf position edits are made, original MLC aperture is retained. Further edit will snap MLC leaves back to original aperture. Isocenter shift made in XIO will also

Cytomics FC 500 Flow Cytometry System Beckman Coulter Inc. 2009-03-02 2009-02-11 46568 Type III 626553 N/Acause same.Erroneous but credible results may be generated when prism plot results are not updated

A) Sterile Pacemaker and Defibrillator Pack Cardinal Health 2009-03-02 2009-02-11 46636 Type II A) SAN30PAXXX A) 872728, 875378consistently when exported to spreadsheet software.The recall has been initiated due to a failure in the sterilization and the manufacturer is

B) Sterile Shoulder PackEnzymatic Creatinine Assay Genzyme Diagnostics P.E.I. Inc. 2009-03-02 2009-02-12 46641 Type II

B) SOP30ASXXXN/A

B) 87201331895, 32120, 32689, 32565, 32383

unable to assure the sterility of these products. Five kit lots of product were incorrectly labelled with a date that extends past their 18 month

Amsorb Plus Prefilled Bubble-Can Universal WTOV Armstrong Medical Limited 2009-03-02 2009-02-05 46652 Type II N/A 08090F12expiration. Upward force of the inner sealing ring on the mating surface of the Drager Clic adapter is insufficient to fully open the gas circuit due to a defect in the plastics body resulting in

Blood Tubing Set for Hemodialysis Nipro Corporation 2009-03-02 2008-12-10 45627 Type II A230TR/V810TR 8102absorbent failure. Cracking of the priming set drip chamber which is pre-attached to the arterial line was reported. Cracking and leaking of the chamber compromises the sterility of the device

A) PDSII (Polydioxanone) Monofilament SutureB) Coated Vicryl Absorable SutureC) PDS II (Polydioxanone) SutureD) Monocryl Plus Antibacterial SutureE) Coated Vicryl Plus Antibacterial Suture

Ethicon Inc. 2009-03-02 2009-02-02 46404 Type II A) Z117H, Z320H, Z969HB) DC512, J286G, J544G, J546G, J547G, J699H, J834G, J945HC) Z-991G, Z305HD) MCP496GE) VCP416H, VCP534H, VCP602H, VCP615H, VCPB340H

A) APM797, APM298, APM980B) APM272, APZ116, APM400, AP6072, APM384, APM401, APM324, APM775, APZ363, AP2615C) APZ490, APM844D) APZ414E) AP2599, APM984, APZ804, APM982, APZ372

raising contamination issues.Ethicon is conducting a recall of 21 lots and 19 corresponding product codes of absorbable sutures for which sterility cannot be assured, due to a failure in the sterilization process.

A) Brilliance CT Big Bore System - Main Unit Philips Medical Systems (Cleveland), Inc. 2009-03-02 2009-02-11 46654 Type II A) 4535 670 88051 A) N/A There is potential for data to be lost during reconstruction of images in which slices can B) Brilliance CT Big Bore System - WorkplaceHemodialysis Blood Tubing Set Fresenius Medical Care North America 2009-03-02 2008-11-27 45519 Type II

B) 4550 110 0203103-2794-0

B) N/A> 10 Numbers, Contact Mfr.

either be disregarded or interleaved based upon their series ID. On specific lot numbers of twister combiset bloodlines a twister port may crack and

Legion Press Fit Stems Smith & Nephew, Inc. 2009-03-02 2009-01-23 46554 Type III 7142-4053 06DM08612separate, which may result in potential blood exposure and/or blood loss for the patient.A Legion 20mm x 160mm stem was packaged as a legion 10mm x 160 mm stem on the outer label. / L’étiquette extérieure sur l’emballage d’une tige de 20 mm x 160 mm fabriquée par la société Legion indique qu’elle est de 10 mm x 160 mm.

Tandem Unipolar 46mm Femoral Heads A) Colleague Volumetric Infusion PumpB) Colleague 3 Volumetric Infusion PumpC) Colleague Guardian Enhanced CXE PumpD) Colleague Guardian Enhanced 3CXE PumpE) French Colleague CXE Volumetric Pump

Smith & Nephew, Inc.Baxter Healthcare Corporation

2009-03-022009-03-02

2009-01-232009-01-28

4655645280

Type IIType II

126646A) 2M8151, 2M8161, DNM 8151 B) 2M8153, 2M8163, DNM 8153C) 2M9161D) 2M9163E) DNM9163

08LM02210A) All Serial NumbersB) All Serial NumbersC) All Serial NumbersD) All Serial NumbersE) All Serial Numbers

A 46mm head was lasered and packaged as a 45mm head. Damaged batteries, 2 specific sequence of events lead to invalid infusion register state, faults in internal communications of pump, pump may short circuit due to fluid ingress or compromised insulation.

F) French Colleague 3 CXE Volumetric PumpPip Fixation Hinge Kit Smith & Nephew, Inc. 2009-03-02 2009-01-29 46558 Type II

F) DNM9163101638

F) All Serial Numbers07DM13310, 08FM16961 Hinges are cracking/breaking pre-op, intra-op, and post-op causing loss of functionality of

A) Advia 1650 Creatinine (CREA) AssayB) Advia 2400 Creatinine 2 (CREA_2) AssayC) Advia 1650 Creatinine (CREA) AssayD) Advia 1200 Creatinine 2 Assay (CREA 2)E) Advia 1800 Creatinine 2 (CREA_2) AssayF) Advia 1800 Creatinine (CREA) AssayG) Advia 2400 Creatinine (CREA) Assay

Siemens Healthcare Diagnostics Inc. 2009-03-16 2009-02-18 46691 Type III A) 03039070B) 03039070C) 03039070D) 03039070E) 03039070F) 03039070G) 03039070

A) 175572616, 175516116, 175518135, 176504-768, 175581661, CA17551062, 175592713, 175597-737, 175535293, 175535294, 175588-693, 175516117, 175518134, CA17501263, 175528239, 175573189, 175542364B) CA12420092, CA12420093, CA12430054, CA12430055C) 175572616, 175581661, 175516116, 175518135, 176504-768, CA17551062, 175592713, 175597-737, 175535293, 175535294, 175588-693, 175516117, 175518134, CA17501263, 175528239, 175573189, 175542364D) CA12240081, CA12240082, CA12220026E) CA12340052F) CA12340052G) CA12420092, CA12420093, CA12430054, CA12430055

the product. Post-op failures have resulted in loss of distraction/reduction.The reagent is not meeting the current on-board stability claims of 20 days without reagent container inserts in the new XL versions of software.

Oxinium Femoral Heads 36mm -3 Smith & Nephew, Inc. 2009-03-16 2009-01-29 46557 Type II 71343603 > 10 Numbers, Contact Manufacturer There is an incorrect radius in the taper of the 36mm -3 heads. This could result in the

GS HBsAg EIA 3.0 Bio-Rad Laboratories, Inc. 2009-03-16 2009-02-16 46713 Type III 32591 164CCC, 179CCC, 235CCCtapers not locking fully or properly on the stems, impingement and/or wear debris.Some tests of the GS HbsAg EIA 3.0 kit have been rejected during real time product stability testings: on “high level,” the optical density of the kit positive control was less than

B) Fastrac Guidewire Gastric Access Kit B) 005739 B) All Lot Numbers which could result in peritonitis and additional adverse conditions.

Cell-Dyn Ruby With System Software V2.0 ML Abbott Laboratories Diagnostic Division 2009-03-16 2009-02-23 46767 Type III 08H67-01 N/A CELL-DYN Ruby system (software V 2.0 ML only) mixer motor can exceed temperature

A) PCR Eleva S PlusB) PCR Eleva Corado

Philips Medical Systems DMC GMBH 2009-03-16 2009-02-23 46769 Type II A) PCR Eleva S PlusB) PCR Eleva Corado

A) N/AB) N/A

specifications per certain safety standard, after cycling power to the analyzer.Possibility that choice of patient will be changed when using filtered work lists. Normally problem detected because the "active" name of patient is displayed. This affects PCR Eleva

Brilliance ICT System-System Philips Medical Systems (Cleveland), Inc. 2009-03-16 2009-02-20 46770 Type II 728306 N/Asystem connected to a RIS. Artifact may appear if combination of 80KV and either a UA, UB or UC filter is used for reconstruction of the images, during brain scans and brain perfusion studies, in Brilliance

Sealapex Xpress Sybron Endo 2009-03-16 2009-02-24 46779 Type II N/A 6-1314, 7-1221, 7-1258iCT systems on software V2.5.0. Sealapex Xpress root canal filling material may contain crystals preventing gutta percha

A) Universal Intra-Aortic BalloonB) Narrowflex Intra-Aortic BalloonC) 9FR Rediguard IAB CatheterD) 8FR 40cc Rediguard IAB CatheterE) 7FR 30cc Rediguard IAB Catheter KitF) Ultra IAB Catheter KitG) Arrow DrivelineH) Ultraflex Intra-Aortic Balloon

Arrow International, Inc. 2009-03-16 2009-02-09 46517 Type I A) IAB-04840-UB) IAB-04830-UC) IAB-R950-UD) IAB-S840CE) IAB-S730CF) IAB-05830-U, IAB-05840-UG) IAK-02691, IAK-02692H) IAB-06840-U

A) > 10 Numbers, Contact ManufacturerB) > 10 Numbers, Contact ManufacturerC) > 10 Numbers, Contact ManufacturerD) > 10 Numbers, Contact ManufacturerE) > 10 Numbers, Contact ManufacturerF) > 10 Numbers, Contact ManufacturerG) > 10 Numbers, Contact ManufacturerH) > 10 Numbers, Contact Manufacturer

points from reaching bottom, which in turn may cause leakage and need for retreatment.Blue connector for 40cc IAB not properly recognized by IAB pump system. Fault in connector of pump tubing assembly may result in volume setting on pump defaulting to 2.5 or 5cc rather than 30,40 or 50cc.

I) Ultra 8 IAB - Lightwave SensorZoll AED Plus Defibrillator Zoll Medical Corporation 2009-03-16 2009-02-14 46732 Type II

I) IAB-05830-LWS, IAB-05840-LWSN/A

I) > 10 Numbers, Contact ManufacturerSerial Numbers Less Than X09B200000 Following a long period (> 4 years) without use, a Zoll AED Plus Defibrillator may prompt

A) Innova 2100IQ X-Ray Imaging SystemB) Innova 4100IQ X-Ray Imaging System

GE Healthcare 2009-03-16 2008-09-09 43319 Type III A) 2335129-4, 2335139-4B) 2335129, 2335129-5, 2335139-2,

A) > 10 Numbers, Contact ManufacturerB) > 10 Numbers, Contact Manufacturer

"change batteries" during use and fail to deliver therapy. Defective battery charger caused the loss of the mains power and unit could not be turned back on. There is no monitoring to warn the user the battery voltage is low and is about to

Datex-Ohmeda AS/3 Anesthesia System GE Healthcare Finland OY 2009-03-16 2009-02-19 44987 Type IIS18741AMN/A > 100 Numbers, Contact Manufacturer

shut down. Patient breathing circuit or tubing of the anesthesia delivery unit (ADU) misconnects. Patient

A) Button Feeding Tube Bard Access Systems, Inc. 2009-03-16 2009-02-10 46551 Type II A) 000256 A) HUSD0351can not be ventilated. Pin of feeding adaptors may not be aligned which create a restriction within the adaptor preventing

B) Button Replacement Gastrostomy Device A) Stardriver Screwdriver, T8, ManualB) Torque Limiting Attachment

Synthes (Canada) Ltd. 2009-03-16 2009-02-12 46653 Type IIB) 000292A) 03.617.902B) 03.110.002.99

B) HUSD0126 & HUSD1972A) N/AB) N/A

food from getting through the occlusion. The labelling is being corrected on page 16 of the zero P instruments and implants technique guide. This is to ensure that surgeons always use the torque limiting attachment

Web, Pocket And Cellular Viewers GE Healthcare Finland OY 2009-03-16 2009-03-04 44728 Type II M1057669 Serial Numbers GB8717D5D4 and GB8747303Cwith the Stardrive screwdriver.1) Possible failure of CIC Pro Alarms. 2) Mobile care software/mobile viewers do not recognize Apexpro FH telemetry transmitter. 3) Mobile care software/mobile viewers and

Ventri Dual Detector Cardiac Camera GE Healthcare 2009-03-16 2009-02-11 44732 Type II N/A Serial Numbers 11259008, 11083011, 11200010, 11016014, 11016013, 11135012,

iCentral might generate false positive alarms.Patient's hand squeezed in the gap between the table and the gantry. Patient suffered a hand cut that had to be sutured.

Galileo Echo Blood Bank Analyzer Immucor Inc. 2009-03-16 2009-02-02 46515 Type II 8700011135012, 00000000VEN004000, 11111018N/A Windows does not allow creation of files with same name, differing only in case (which is

possible with Echo software). Interpretation of last result written will be superimposed on

E.CAM PHS FOV Siemens Medical Solutions USA, Inc. Molecular Imaging Group

2009-03-16 2009-02-03 46563 Type III 4366618, 4381088 > 10 Numbers, Contact Manufacturerwith the first result written.Customer safety advisory notice regarding patient attempts to pull themselves up using the patient handling system field of view flip-up armrests without assistance, chance that fingers

AxSym Sustem Tubing Decontamination Solution Abbott Laboratories Diagnostic Division 2009-03-16 2009-02-24 46832 Type II 7A83-01 211974can get pinched. Bottle labels from lot 211974M AxSYM System Tubing Decontamination Solution (list number 7B05-09), were found to be missing the following information: lot number, date of

Periowave Photo-Disinfection System Ondine Biopharma Corporation 2009-03-16 2008-11-25 46928 Type III N/A N/Amanufacture, and expiration date.Manufacturer has determined that the recently manufactured Periowave Photo-Disinfection laser base stations supplied with the plastic base plate (PW1100) do not conform to the

A) Advia 1200 Total Protein II (TP) AssayB) Advia 1800 Total Protein II (TP) AssayC) Advia 1650 Total Protein II (TP) AssayD) Advia 2400 Total Protein II (TP) ASSAY

Siemens Healthcare Diagnostics Inc. 2009-03-16 2009-03-03 47005 Type III A) 01803350B) 01803350C) 01803350D) 01803350

A) CA12250055, CA12250088, CA12260006, CA12240081, CA12240082, CA12260038, CA12220026B) CA12330010, CA12330020, CA12320094, CA12330001, CA12310068, CA12310069, CA12300004, CA12320093, CA12340052, CA12320088, CA12320015, CA12320016, CA12310091, CA12320089, CA12310055, CA12310054C) 175542364, 175535294, 175535293, CA17551062, CA176504-768, 175572616, 175581661, CA175588-693, CA12250055, 175516116, 175518135, 175573189, 175516117, 175518134, CA17501263, 175528239, 175592713, 175597-737 D) CA12430022, CA12430055, CA12440034, CA12440035, CA12440048, CA12440092, CA12420093, CA12430054, CA12440038,

current EMC standard. Research and development studies determined that freshly opened reagent does not pass the Dextran Interference Specification.

A) Fastrac "Pull" Gastric Access Port Kit Bard Access Systems, Inc. 2009-03-16 2009-02-11 46553 Type II A) 005729CA12440033A) All Lot Numbers Premature balloon deflation when exerting excessive tightening of the external bolster,

Proximal Tibial Components.

A) Aisys Anesthesia Carestation -Main UnitB) Aisys Anesthesia Carestation - TrolleyC) Aisys Anesthesia CarestationD) GE Datex-Ohmeda Avance Anesthesia SystemE) GE Datex-Ohmeda Avance Anesthesia System - Trolley

Datex-Ohmeda, Inc. 2009-03-16 2009-03-02 46656 Type II A) 1011-9000-000B) 1011-8302-000C) 1011-8109-000D) 1009-9002-000E) 1009-8134-000

A) S/N'S ANAH001122 & ANAJ00132B) > 10 Numbers, Contact Manufacturer C) S/N'S ANAJ00131, ANAJ00133, ANAK00110, ANAK00111, ANAK00112, ANAK00113, ANAK00114, ANAK00115D) S/N'S ANBL01967, ANBL01990, ANBM00367, ANBH00291

Failure of the electrical portion of the on/standby switch causes the system to shutdown without clinical intervention, causing the patient to experience hypoventilation leading to hypoxia.

Swan-Ganz Continuous Cardiac Output Edwards Lifesciences LLC 2009-03-16 2009-02-09 46971 Type II 744HF75, 746HF8E) > 100 Numbers, Contact Manufacturer > 100 Numbers, Contact Manufacturer Cardiac output measurements were unavailable and the following fault message was

displayed in vigilance monitors: "fault. CCO catheter verification use bolus mode" instead of

Orthocord Violet Braided Composite Suture Depuy Mitek 2009-03-16 2009-02-03 47042 Type II 223105 AP2546continuous output mode.Unable to assure sterility due to a failure in the sterilization process. Subject suture was impacted by the same sterilization process failure reported for Vicryl, Monocryl and PDS II

Instrument Manager Data Innovations 2009-03-16 2009-02-17 47050 Type III N/A Specimen Management Database Version 8.07 sutures in recall #46404. 'Any test is rerun' data element may not trigger a rule to fire even though a test is marked

Instrument Manager Data Innovations 2009-03-16 2009-02-17 47057 Type III N/AAnd 8.08Specimen Management Database Version 8.07

as a rerun in the specimen management database. Specimen management rules may fire inconsistently when evaluating tests using nested

A) Trigen Trochanteric Antegrade NailsB) Trigen Trochanteric Interlocking Nails

Smith & Nephew, Inc. 2009-03-16 2009-02-27 46974 Type II A) 7163-8232, 7163-8242, 7163-8336, 7163-8344

Or HigherA) 08KM06602, 08KM08612, 08KM06604, 08KM07560

rules (parent/child). Product was distributed with non-compliant labelling. Label colour codes and graphics were left off of the outer labels.

Intertan Lag/Compression Screw Kit Smith & Nephew, Inc. 2009-03-16 2009-02-26 46975 Type IIB) 71633130, 7163313471677105

B) 08KM12411, 08KM1240306GM11410 Screw kits were distributed containing 2 compression screws instead of 1 each of a

compression screw and a lag screw. As this device is distributed in sterile packaging, the

Axsym Cancer Assay Disk Version 5.0 Abbott Laboratories Diagnostic Division 2009-03-16 2009-03-05 47105 Type III 03D50-05 N/Aissue may not be immediately evident. The sample dilution low concentration flag for 1:101 automated dilution protocol fluid for the AxSYM AFP Assay file (3 0 100) on the device allows the instrument to report results

Elements Gutta Percha Cartridge Sybron Endo 2009-03-16 2009-03-06 47107 Type III N/A N/Abetween 0ng/ml and 0.4ng/ml. Two labels were left off package. Caution: device sale restricted to dentists and contains dry

Take 1 Advanced LB Wash Super Fast Set Kerr Corporation 2009-03-16 2009-03-06 47112 Type III 33955 8-1182natural rubber. The outer packaging of dental impression material, Take 1 Advanced LB Wash Super Fast Set, has two contradicting labels: Light-Body Fast Set and Super Fast Set. The product

Navistar RMT Diagnostic/Ablation CatheterUpdated recall # 41193 previously posted on 2008-

Biosense Webster Inc. 2009-03-30 2008-02-28 41193 Type I NR7TCSIY All Lot Numbers contains Super Fast Set.The device exhibited characteristics that are inconsistent with the product specifications. In some cases, char and coagulum have been observed.

03-17. Fusion Oasis One Action Stent Wilson-Cook Medical, Inc. 2009-03-30 2009-02-24 46763 Type II FS-OA-10 CFW462190 Secondary package graphic label indicates wrong product (Fusion Extraction Balloon). All

Near Empty Flags Smiths Medical MD Inc. 2009-03-30 2009-03-05 47084 Type II 0131-0122, 0131-0236 Contact Manufacturerother package and internal labelling is correct.Certain Near Empty Flags, sold in Near Empty Flag Kits(0131-0122) and in Halfnut, Leadscrew & Flag Kits(0131-0236), for use in Graseby 3000 Syringe Pumps, may become

A) Medfusion Syringe Infusion PumpsB) Medfusion Keypads

Smiths Medical MD Inc. 2009-03-30 2009-03-05 47083 Type II A) 3500-306, 3500-415B) G6000607, G6000771

A) > 10 Numbers, Contact Manufacturer B) P120300, P121344, P127163

dislodged rendering Near Empty Alert inoperable. Since issuing a recall in December 2008, Smiths Medical has found that one lot of keypads, in some fully assembled pumps and some kits, is predisposed to short circuits which can

C) Medfusion Top Case AssemblySpecimen Gate Laboratory Wallac OY 2009-03-30 2009-01-15 47157 Type II

C) G60007375002-0180

C) M59050, M59505, M60280Version 1.2 REV2, Version 1.3

render the keypad inoperable.Defect associated with result viewer's "view assay" button in the "specimen history" screen. Laboratories using this feature, as well as a very specific sequence of events, may be

Therasphere Administration Set MDS Nordion 2009-03-30 2009-02-23 46822 Type II 990226.SPE N/Aimpacted. There are no instructions on the package insert for the use of the pinch clamp that is an

Synchron Systems Gentamicin Reagent Beckman Coulter Inc. 2009-03-30 2009-03-09 47011 Type II 469137 M804552integral part of the Therasphere Administration Set. Beckman Coulter has confirmed greater variability, and low recovery values on at the low end of the therapeutic range (<1.5 ug/ml, <3.13 umol/l) with Synchron Systems Gentamicin

A) Multidiagnost Eleva Philips Medical Systems Nederland B.V. 2009-03-30 2009-03-09 47191 Type II A) 70832 A) N/AReagent (GEN) lot M804552.Images from two different patients may be combined in one patient folder in the digital

B) Omnidiagnost ElevaA) Advia 1650B) Advia 1800

Siemens Healthcare Diagnostics Inc. 2009-03-30 2009-03-09 47200 Type IIIB) 708027A) 06363413, 073-B002-01, 10324237B) 01412173, 02416873, 073-A021-01,

B) N/AA) > 10 Numbers, Contact ManufacturerB) > 10 Numbers, Contact Manufacturer

imaging or may be combined as one (printed) image.The default ratio definition of the calculation for %HBAIC has been confirmed that the calculation is incorrect for Advia 1650, software version 4.01.01, and for Advia 1800,

Centricity PACS Workstation - Software GE Healthcare Integrated IT Solutions 2009-03-30 2009-01-22 46162 Type II10315183N/A > 100 Numbers, Contact Manufacturer

software version 1.01.01.Potential patient safety concerns, under certain conditions, involving patient jacket content,

Omnifuse PCA Syringe Pump Smiths Medical MD Inc. 2009-03-30 2009-01-27 46274 Type III 0153-0711 N/Awhich may result in unintended historical image(s) being displayed.Following the release of the Omnifuse upgrade utility (recall #42817) it was discovered that the options to upgrade French and Dutch language pumps did not correctly install some

SoftPath GUI v. 4.2.3.4,4.2.4.1,4.3.0.4 SCC Soft Computer 2009-03-30 2009-01-26 46600 Type II GUI VERSION 4.2.3.4, GUI VERSION 4.2.4.1, GUI VERSION 4.3.0.3, GUI

N/Alanguage text into the pump. The previous patient history and some QA management reports may have missing or incorrect diagnosis text.

Syngo Dynamics Workstation Software Siemens Medical Solutions USA, Inc. 2009-03-30 2009-02-05 47063 Type IIIVERSION 4.3.0.4100 90 597, 100 90 599 > 10 Numbers, Contact Manufacturer Under certain circumstances, when editing text in a report, it may result in additional phrases not

Syngo Imaging C.S.A.N. Siemens AG 2009-03-30 2009-02-11 47068 Type III 10 014 063 1200populating as expected.Customer safety advisory notice to inform customer of potentially defective stored image

AED 10 Welch Allyn Protocol, Inc. 2009-03-30 2009-02-26 47076 Type I 970300, 970302E, 970308E, 970309-E, > 10 Numbers, Contact Manufacturerdata on long term storage. Problems with the AED 10 defibrillator: 1. Low energy delivery 2. Blown fuse 3. Loss of

MRS Cemented Stems Howmedica Osteonics Corporation 2009-03-30 2009-03-05 47104 Type II970310E, 970311E, 970311U6485-3-010, 6485-3-018, 6485-3-019 TEC231A, TEC077, TEC078B

voice prompt 4. Electromagnetic noise filtering 5. Shutdown. There are no warnings on the label or IFU that the 8, 9, 10mm diameter MRS Cemented Heads should only be used with the GMRS Distal Femoral Components and the GMRS

possibility that the performance of the cartridge assay may be impacted. Flow-Set Fluorospheres Beckman Coulter Inc. 2009-04-13 2009-03-16 47347 Type II 6607007 7524003F, 7524004F, 7524005F, 7524006F Current flow set labelling does not provide new target settings for tetra applications.

ILED Surgical Lighting Systems Trumpf Kreuzer Medizin Systeme GMBH & Co. KG 2009-03-30 2009-03-16 47210 Type II ILED3, ILED5, ILED5K 100268621 to 100717475 The cover plates on these surgical lights can be damaged by certain disinfectants. Cracks can form around the screw connections of the cover plates and the material can become

Symbia T, T2, T6, T16 Siemens Medical Solutions USA, Inc. Molecular Imaging Group 2009-03-30 2009-02-26 47218 Type II 10275007, 10275008, 10275010 1056, 1012, 1058brittle and fragments break off.The pinion gear could crack and may cause damage to the systems. Damage to the pinion gear may cause the gantry to spin freely. Replacement of the pinion gear is mandatory.

A) Disposable Singular Polypectomy SnaresB) Disposable Optimizer Polypectomy SnareC) Entake Peg Push Safety KitD) Entake Peg Pull Safety KitE) Entake Peg Push Standard KitF) Entake Peg Pull Standard Kit

Conmed Endoscopic Technologies, Inc. 2009-03-30 2008-12-04 45614 Type II A) 000957, 000958, 000959, 000960, 000963, 000964, 000965, 000977, 000978, 000979, 000980, 000983, 000984, 000985, 000986, 000987, 000988, 000991, 000992B) 000460, 000461, 000462, 000463, 000464, 000465, 000466, 000467, 000472, 000473, 000474, 000475, 000476, 000477, 000478, 000479C) FESG20NDD) FESP20NDE) FEXG20ND

A) 0605011 Through/Including 0805311B) 0605011 Through/Including 0805311C) 0605011 Through/Including 0805311D) 0605011 Through/Including 0805311E) 0605011 Through/Including 0805311F) 0605011 Through/Including 0805311, 0807161 Through / Including 0811202

The manufacturer has noticed an increase in the number of complaints of snare (loop) detachment from the device.

Linear Accellerators Siemens Medical Solutions USA, Inc. Oncology Care Systems 2009-03-30 2009-02-26 47066 Type IIIF) FEXP20ND1940035, 4504200 3235, 3236, 3356, 3645 Safety advisory letter concerning the apparent inconsistency in the direction of gantry

rotation during an auto-sequenced delivery, affects when using console versions CC6.2

Acuson S2000 Siemens Medical Solutions USA, Inc. 2009-03-30 2009-02-24 47069 Type III 10041461 200288, 200583, 200591, 200593, 200599, 200252, 200334

through CC9.1. 1. Data framing an image could be leftover from a previous patient and may or may not include measurement results.2. If the last image stored is an elastogram, it may appear as the first image of the next patient.

A) Alumina Ceramic Femoral Head 28mmB) Alumina Ceramic Femoral Head 32mm

Zimmer Inc. 2009-03-30 2009-02-23 47128 Type II A) 00-6428-028-01, 00-6428-028-02, 00-6428-028-03

A) All Lot NumbersB) All Lot Numbers

Labelling will be changing to indicate that these heads should not be combined with Zimaloy hip stems made from castings. Labelling for the applicable case Zimaloy/cobalt-chrome hip

A) Radiolucent Spine Reference Clamp Kit Brainlab AG 2009-03-30 2009-02-03 46474 Type II

B) 00-6428-032-01, 00-6428-032-02, 00-6428-032-03A) 55757 A) N/A

stems will also be changed.

A combination of Spine Reference Clamp(55756) with any other array or extension then the B) Radiolucent Spine Reference Clamp

A) Darco 2.5 Cannulated Hex Screwdriver Wright Medical Technology Inc. 2009-03-30 2009-02-19 46951 Type III

B) 55756

A) DC4261

B) 6001607001

A) > 10 Numbers, Contact Manufacturer

intended array(55753), allows for rotation of the reference array even though the mounting nut is tightly closed. 2 of 3 sterilization methods (by gravity displacement) listed in package insert for Darco

B) Wright Express Kit B) DMRSKIT1 B) > 10 Numbers, Contact Manufacturer Cannulated Hex Screwdriver, sold alone and as part of the Wright Express Kit, haven't been validated for this instrument.

Architect Reaction Vessels Abbott Laboratories Diagnostic Division 2009-03-30 2009-03-04 47027 Type III 7C15-01 > 50 Numbers, Contact Manufacturer Reaction Vessels manufactured from a specific lot of resin have an increased likelihood of producing error code 1006, error code 1007 and incorrect patient results.

Truncated Blade Zimmer Trabecular Metal Technology, Inc. 2009-03-30 2009-03-12 47373 Type II 00-7053-058-10 60682170 The catalogue number etched on the instrument reads "7053-58-20" and it should read "7053-58-10". The incorrect catalogue number corresponds to full blade.

I-STAT EG7+ Cartridges Abbott Point Of Care Inc. 2009-03-30 2009-02-23 47216 Type II N/A P08274A Certain boxes of i-STAT EG7+ Cartridges have sub optimal pouch seals. There is the

C) Vitros Chemistry Slides - CSF Protein C) 8208431 impact performance.D) Vitros Chemistry Slides - Total Bilirubin D) 8159931

A) Percutaneous Sheath Procedural KitsB) Central Venous Catheterization Set/KitC) Temporary Pacing CatheterD) Two-lumen Central Catheterization KitE) Percutaneous Sheath Introducer SetsF) StopcocksG) Arterial Access ProductsH) Thrombolic Device Rotator Drive UnitI) Tretorola Percutaneous Thombolic DeviceJ) Percutaneous Sheath IntroducerK) Super Arrow-Flex Percut Sheath IntroL) Stopcock with Luer LockM) Stopcock ManifoldN) Multi-Lumen Percut Sheath IntroducerO) Stopcock with Luer LockP) Stopcock with Luer LockQ) Blood Administration SetsR) Extension SetsS) Trerotola Percut. Thrombolytic Kit

Arrow International, Inc. 2009-04-13 2009-02-18 46908 Type II A) AK-09903-J, CA-09803, CA-09886, CA-09903-LF, RV-09803, SB-09803, SB-09883-S, SB-09907-S, SP-09801B) AK-14703-J, AM-15703-JC) AI-06210-IK, AI-7155-IKD) AK-17702-JE) CL-07011, CL-07024, CL-07045, CL-07065, CL-07080, CL-071165, CL-071180, CL-07511, CL-07524, CL-07545, CL-07590, CL-07611, CL-07624, CL-07635, CL-07645, CL-07665, CL-07690, CL-07700, CL-07711, CL-07724, CL-07735, CL-07745, CL-07765, CL-07780, CL-07790-R, CL-07800, CL-07824, CL-07835, CL-07845, CL-07880, CL-07924, CL-07965, CL-07980, CP-07011, CP-07511, CP-07611, CP-07711, CP-07811, CP-07911, CR-07645, CR-07745F) SC-00001, W-15549, W-19922G) AA-00611, AA-15511, AA-15511-S, AA-15611, AA-15611-S, AA-15624H) PT-65509-HFCI) PT-45509J) CA-09801, CA-09807, MTO-09801-CHAK) CL-08403, CL-08503, CL-08503-A, CL-08603, CL-08605, CL-08605-HF, CL-08703, CL-08705-HF, CL-08803, CP-08403, CP-08503, CP-08603, CP-08603-P, CP-08703, CP-08803, CP-08903, CW-

A) Contact ManufacturerB) Contact ManufacturerC) Contact ManufacturerD) Contact ManufacturerE) Contact ManufacturerF) Contact ManufacturerG) Contact ManufacturerH) Contact ManufacturerI) Contact ManufacturerJ) Contact ManufacturerK) Contact ManufacturerL) Contact ManufacturerM) Contact ManufacturerN) Contact ManufacturerO) Contact ManufacturerP) Contact ManufacturerQ) Contact ManufacturerR) Contact ManufacturerS) Contact Manufacturer

Material used in the manufacture of these products is not lipid resistant and could be weakened during the administration of lipid solution.

Access Systems Total BHCG Reagent Kit Beckman Coulter Inc. 2009-04-13 2009-03-16 47348 Type II

08703, CW-08803, IC-09880L) W2004133500 824542, 825652 There is an increase in background relative light units (RLU) when comparing results

1550 Electric Stetcher With Quick Drop Stryker Medical 2009-04-13 2009-03-16 47353 Type II 1550-000-000 > 100 Numbers, Contact Manufacturer

between when a pack is first mixed/loaded and after it has settled on the instrument for 10 hours or more. This may produce a shift in results. Stretcher fowlers (backrests) may develop a grinding noise from wear of drive nut threads in the fowler. If the stretcher continues to be used, the fowler may inadvertently drop to its

C2A Ringloc Acetabular System - 28 mm Biomet Orthopedics, Inc. 2009-04-13 2009-03-16 47389 Type II 12-115112(RD115112) All Lotslowest (flat) position.Possibility of ceramic heads fracturing with +5mm offset.

Bard Max-Core Disposable Biopsy Instr. Bard Peripheral Vascular, Inc. 2009-04-13 2009-03-09 47251 Type II MC1810, MC1816, MC1820 RESH0255, RESH0057, RESH0736, RESI0279, RESI0451

Incorrect label. Label indicates a length of sample notch of 1.9cm (19mm), where actual product is 1.8cm (18mm), a potential difference of 1mm in length.

Hill ROM Totalcare Bed

Norwex Silvercare Toothbrush

Hill-ROM Company, Inc.

Norwex Enviro Products Inc.

2009-04-13

2009-04-13

2009-03-09

2009-03-17

47219

47238

Type II

Type II

N/A

22963

J329AMXXX to J340AM1369

N/A

E-ring may not fully be seated on the siderail bracket. It could cause the e-ring to be missing and could result in an inability to latch the siderail. Toothbrush head may pose a choking or swallowing hazard to children under three years of age or to individuals that would normally require supervision or assistance brushing their teeth.

A) Option + Sterile PADS 5cm X 5cmB) Option + Steriles PADS 10cmX10cmA) Heparin pre-filled syringes

Uniprix Inc.

Medxl Inc.

2009-04-13

2009-04-13

2009-03-13

2009-03-29

47475

47632

Type III

Type II

A) 771290064484B) 771290064491A) 3706, 3780, 3781, 3786, 3787

A) 10380, 10381B) 10381A) All lots between 6892 and 8180

Some sterile pads that had not been sterilized were released for sale.

Complaints received about discolouration and particulate matter contamination. B) Saline pre-filled syringes B) 3704, 37043, 37043B, 37043BNC, B) All lots between 6892 and 8180

Byrd Screw 2.0x6mm Self Drilling5/0 Polyglycolic Acid Absorbable Suture

Walter Lorenz Surgical, Inc. Also Trading As: Biomet MicrofixationAce Surgical Supply Co. Inc.

2009-04-132009-04-13

2009-02-202009-02-24

4672147393

Type IIType II

3705C, 3705NC, 370601-026734630

91807107081031-07

The 01-0267 Byrd screw may break when being used. A small and limited number of packaged product demonstrated a partial delamination, or

Restoration Modular Cone Bodies Howmedica Osteonics - Stryker Ireland 2009-04-13 2009-03-27 47576 Type II 6276-1-121, 6276-1-125, 6276-1-219, 22125701, 21834602, 21883201, 21883401

coming apart, of the two layers of material that make up the clear portion of the outer packaging. Packaging test logs indicate burst test results fell below validation parameters. There may be

Percutaneous Combination Stent Boston Scientific Corporation 2009-04-13 2009-03-23 47581 Type II

6276-1-325

410-111, 410-112, 410-126, 410-202, > 100 Numbers, Contact Manufacturer

deterioration of short or long term packaging integrity (inner or outer) with potential loss of sterility.

During the attempted removal of the device, sutures were separated from the catheter and

Medical Flat Panel Power Supply Spacelabs Medical, Inc. 2009-04-13 2009-03-25 47582 Type II

410-203, 410-204, 410-205, 410-206, 410-207, 410-304, 410-305010-1619-00, 010-1655-00 0647, 0703, 0706, 0707, 0709, 0712, 0724,

remained in the patient. In one instance surgical intervention was opted to remove a suture.

The external power supply used with certain models of the Spacelabs Medical 19" flat panel

Synchron System Total Bilirubin Reagent Beckman Coulter Inc. 2009-04-13 2009-04-06 47692 Type III 442745, 476861

0727, 0728, 0732

N/A

displays may fail prematurely, causing the display to go blank. Audio alarms continue to function normally.A metabolite of naproxen, O-desmethylnaproxen, has demonstrated a positive interference with the Jendrassik-Grof method of measuring Total Bilirubin, leading to spurious elevation in Total Biliruben levels.

Synchron Phosphorus (PHOSm) Reagent

A) Vitros Chemistry Slides - CreatineB) Vitros Chemistry Slides - Enzymatic CO2

Beckman Coulter Inc.

Ortho-Clinical Diagnostics Inc.

2009-04-13

2009-04-13

2009-04-06

2009-03-31

47693

47712

Type III

Type III

467868 M808353, M808354

A) 680 2584B) 8262396

The Phosphorus Reagent (PHOSm) may fail calibration approximately three to six days after loading on some Synchron systems. The foil wrapper for specific lots of slide cartridges may have been damaged during the packaging process. Exposure of slides to uncontrolled environmental conditions could

Leckey seating systems: mobile advance seat, contoured advance seat, squiggles early sitting system, squiggles saddle seat.

Coronary Scissors 7" Teleflex Medical 2009-04-13 2009-03-09 47208 Type II 352164, 352165, 352166, 352167, Date Codes RR8, SS8, TT8, UU8, VV8, WW8, Manufacturing defect consisting of a rough square finish to the scissor tips, rather than a

Servo 300 Maquet Critical Care AB 2009-04-13 2009-03-27 47623 Type II

352168

6079300, 6079391, 6079433, 6150614,

XX8, MM9.

> 10 Numbers, Contact Manufacturer

smooth rounded point, may cause damage to the inner wall of the blood vessel, rendering it unsuitable for bypass graft.Printed circuit boards have stopped working, results in expiratory valve staying in the open

Truguide Coaxial Biopsy Needle Bard Peripheral Vascular, Inc. 2009-04-13 2009-04-01 47695 Type II

6424704, 6424779

C1410A, C1810B, C1813B, C1816B, > 10 Numbers, Contact Manufacturer

position, sometimes preceded by a short valve closure. Remote hazard of serious adverse health consequences. Black circle on pouch label for C2013B stated "for use with Bard MaxCore or Monopty

Paradigm Silhouette Infusion Sets Unomedical A/S 2009-04-13 2009-04-01 47734 Type II

C1820B, C2013B, C2016B, C2020B

MMT-377600, MMT-378600, MMT- 617095, 616520, 616521, 617090, 617094,

Instruments", instead of "for use with MAGNUM Instruments and Biopsy Needles or Biopty Instrument and Biopty-Cut Needles".A typographical error in the fixed prime volume listed in instructions for use. IFU tells users

381600, MMT-382600 616522, 617089, 617093, 616523 to fill empty space in the cannula with a fixed prime volume of 0.3 units of U-100 insulin, instead of 0.7 units.

GT Series X

Factor II (Prothrombin) G20210A Kit

Dentsply Tulsa Dental Specialties Trading As Dentsply EndodonticsRoche Molecular Systems, Inc

2009-04-13

2009-04-27

2009-03-30

2009-04-06

47759

47434

Type III

Type III

SXR0602021, SXR0602025

3610195001

073008100, 062608322

All Lots

25mm length files were mislabeled as 21mm (SXR0602021), and 21mm length files were mislabeled as 25 mm (SXR0602025). The macro component intended to be used with the Factor II G20210A Kit for LightCycler 2.0 instrument may erroneously identify the C20209T mutation as a wild-type genotype instead of an unknown genotype.

Delfia Xpress PAPP-A Wallac OY 2009-04-27 2009-03-26 47713 Type III 6003-0020 510998, 515079, 511590 Some tracer bottles in the Delfia Xpress PAPP-A kit have bar codes which cannot be read in the Delfia Xpress instrument.

A) IV Set with Universal Spike, 2 UltrasiteB) Primary IV Set with 3 Ultrasite

B. Braun Medical Inc. 2009-04-27 2009-03-27 47750 Type II A) 352049/CSP152VSLB) 352049, 375100

A) 61028769, 61028767B) 61029904, 61029908

Investigation for occlusion/no flow identified that disks involved in the low pressure check valve to have not been polyisoprene coated.

A) Grieshaber Handpiece, MPC MicroscissorsB) Vertical ScissorsUpdate Recall # 35431 previously posted on 2007-06-11.

Alcon Grieshabe AG

Siemens AG

2009-04-27

2009-04-27

2009-04-06

2007-05-24

47782

35431

Type II

Type III

A) 705.52B) 704.52A) 10 014 142, 10 014 154, 10 014 155B) 8462645

A) F53125, F58670, F65194, F67471, F69429B) F61426, F63004A) 3901384286B) 3904116228, 3904115986

New metal cannula assemblies are scheduled for launch in June 2009. These new metal cannula may have a tolerance stack up issue with selected lots of these scissors. Hardware component is near end of expected life cycle and the RAID Controller can cause a system crash resulting in a loss of data.

A) Magic Store SystemB) Sienet MagicstoreA) Syngo Dynamics SD 6.0 Server Software Siemens Medical Solutions USA, Inc. 2009-04-27 2009-02-03 46562 Type III A) 100 90 370, 100 90 480 A) 95243, 92241, 95248, 93901 There is potential issue in the syngo Dynamics 6.0 reporting system. Under certain B) Syngo Dynamics SD 6.0 Workstation Software B) 100 90 257 B) 93477 circumstances, when editing text in a report, it may result in additional phrases not

populating as expected.A) Cell-Dyn 3700 SL AnalyzerB) Cell-Dyn 3700 CS Analyzer

Abbott Laboratories Diagnostic Division 2009-04-27 2009-04-01 47694 Type III A) 02H31-01B) 02H30-01

A) All Serial NumbersB) All Serial Numbers

There have been occurrences of visible fire and smoke from the analyzer. They may contain the incorrect fuse for the electrical configuration at the customer site.

Holter

Neogram Amino Acids Mass Spec Kit

Philips Medical Systems

Wallac OY

2009-04-27

2009-04-27

2009-03-30

2009-04-01

47704

47714

Type II

Type II

1810, 2010+

3026-0010, 3026-0030

N/A

Contact Manufacturer

Holter software version 2.9 and 2.9.1 may contain problems which could affect its performance. The truncated V-Bottomed Microplates delivered as a package of 10 plates may have

A) Combi SlingB) Combi Sling Deluxe ChildC) Combi Sling Mesh Deluxe ChildD) Combi Sling Deluxe OversizeE) Combi Sling Mesh Deluxe Oversize

BHM Medical Inc. 2009-04-27 2009-04-03 47789 Type II A) 626002B) 626002CC) 626002C-MD) 626003E) 626003M

A) N/AB) N/AC) N/AD) N/AE) N/A

occasional contamination which results in an apparent elevated C4 concentration in an affected well.A premature failure of the stitching at the junction of the shoulder strap and the sling body can lead to the detachment of the shoulder strap resulting in possible patient fall.

F) Combi Sling Oversize Heavy DutyG) Combi Sling Mesh DeluxeA) Sterrad 50 Sterilizer System Advanced Sterilization Products, A Division Of Ethicon 2009-04-27 2009-03-13 47825 Type II

F) 626003XG) 626002M A) 10050

F) N/AG) N/AA) > 10 Numbers, Contact Manufacturer The Sterrad 50 system may potentially have defective oil fill plugs. Degradation of the nylon

B) Sterrad NX Sterilizer System B) 10033 B) > 10 Numbers, Contact Manufacturer 6-6 plugs over time, if exposed to hydrogen peroxide, can contribute to emission of oil mist from the sterilizer.

TD-Synergy Software On TD-Microbiology

Heartstart XL

Technidata S.A.S.

Philips Medical Systems

2009-04-27

2009-04-27

2009-04-02

2009-04-09

47834

47915

Type I

Type II

TD-SYN-01

M4735A

N/A

S/N US00442485 to US00469873

MIC (Minimum Inhibitory Concentration) result interpretation can be corrupted and an antibiogram could be reported as sensitive instead of resistant or vice versa. The rotary energy switch may fail and prevent the user from turning the device on, rendering it

Heartstart MRX Defibrillator / Monitor Philips Medical Systems 2009-04-27 2009-04-09 47916 Type II M3535A, M3536A S/N US00210406 TO US00333123

unusable for monitoring and defibrillation therapy. The failure may also occur by spontaneously powering on.The therapy switch has a small potential to fail. Most likely failure mode is spontaneous turn-on which could deplete the battery, rendering the device unstable until power is restored.

Philips BougiesList No. 620 PCS2 Harness Set

Coloplast A/SHaemonetics Corporation

2009-04-272009-04-27

2009-01-232009-04-13

4637347918

Type IIType III

AG55XX00620-00

All Manufactured Between 2003-2008LN 081219511 and 081219512, LN 081222510 and 081222511,

Product recall due to the possibility that the device tip could break during use.This recall is the result of reports of leaks at the blood filter of the Haemonetics lN620 PCS2 Plasma Harness Set.

Wizard Replacement Gastrostomy Device Bard Access Systems, Inc. 2009-04-27 2009-01-16 46066 Type II 00201W, 00202W, 00204W, 00205W,

LN 081223510 and 081223511, LN 081224510 to 081224512> 10 Numbers, Contact Manufacturer Difficulty inserting or removing the feeding adapter cannula into the device.

A) Cognis CRT-D HEB) Cognis CRT-D

Cardiac Pacemakers Incorporated 2009-04-27 2009-04-03 47936 Type II

00207W, 00214W, 00215W, 00223W, 00224WA) N106B) N107

A) N/AB) N/A

Right ventricular lead complications may cause additional over-sensing ,thereby increasing the probability of inappropriate therapy.

C) Teligen ICD (VR-HE DF1)D) Teligen ICD (DR-HE IS-1)

C) E102D) E110

C) N/AD) N/A

A) Contak Renewal 4 CRT-DB) Vitality 2 AcidLeckey Four-Point Pelvic Harness

Cardiac Pacemakers Incorporated

Leckey (James Leckey Design)

2009-05-11

2009-05-11

2009-03-04

2009-04-15

47031

47922

Type II

Type II

A) H-190, H-197, H-199B) T165, T167, T175, T177122-719

A) N/AB) N/ALEC/019910-LEC/043681

Potential for reduced ERI to EOL time in a subset of implantable defibrillators, due to degradation of a low-voltage capacitor. The central plastic buckle degrades and can fail in use. The belts are used in the James

to power up which resulted in loss of both visual and secondary alarm enunciation from the LCD flat panel.

A) Endopath Endoscopic Linear Cutters Ethicon Endo-Surgery, LLC 2009-05-11 2009-04-08 47966 Type II A) LONG45A A) E4MM23, E4MP4A, E4MT4Y The mechanism which connects the articulation joint to the device shaft may be insufficient. B) Endopath Endoscopic Linear CuttersC) Endopath Endoscopic Linear Cutters

B) ATB45, ATW45C) NAW45

B) E4MH2L, E4MG9M, E4ML6J, E4MH18C) E4MJ3K, F4MX8C, F4N799

This may cause the jaws of some of the affected Endoscopic Linear Cutters to remain closed and clamped down on tissue.

Eccentric Bushes Kaltenbach & Voight GMBH 2009-05-11 2009-01-18 47039 Type III 0.535.4692 N/A A nonconformance with the Eccentric Bushes can result in a rough surface that will result in altered revolutions per minute(RPM) and the lifetime of the device.

In-Situ Bender/Cutter Synthes (Canada) Ltd. 2009-05-11 2009-04-09 47833 Type II 530.521S, 530.522S All Lots During examination of shelf life samples as part of real time shelf life validation, the company became aware of and confirmed a breach of the sterile pouch barrier.

Synchron Systems Ammonia (AMM) Reagent

A) Somatom DefinitionB) Somatom Definition AS

Beckman Coulter Inc.

Siemens AG

2009-05-11

2009-05-11

2009-04-08

2009-04-14

47835

47910

Type II

Type III

439770

A) 77 40 769B) 8098027

M808278

A) 60148, 60199, 60206, 60235, 60332, 60348, 60422

The ammonia reagent may fail calibration or cause a low shift in quality control recovery (may recover below the limits of the established range) on some Synchron systems. Update the software on bugfixes (i-triggered sequence, bolus monitoring, 3D recon, reconstruction of raw data, 3D intervention, patient delete, AW hangup), kernel changes,

Unicel DXC 600I Synchron Access Systems Beckman Coulter Inc. 2009-05-11 2009-04-14 47926 Type III A27318

B) 64032, 64049, 64052, 64069, 64137, 64141, 64233, 64238, 64306, 64316Software V.4.0, Software V.3.0

graphic driver, and Microsoft hotfix.

If a sample is manually loaded to the access 2I and no program is at the access 2I or DXC

Vumax Ophthalmic Ultrasound Scanner Sonomed Inc. 2009-05-11 2009-04-13 47987 Type II SHFS35-S 3550-0207-0178, 3550-0108-0244, 3550-0207-0177, 3550-0408-0258, 3550-0707-0213, 3550-0707-0215, 3550-0708-0271, 3550-0907-0220, 3550-0908-0277, 3550-0908-0278, 3550-0108-

console, a program is sent by the LIS only to the DXC console and the sample will not be processed at the access 2I. The Vumax Ophthalmic Ultrasound System may, under certain circumstances, return measurement values on the order of 1/2 or 2x the actual value. Root cause is a software conflict within software version V2.0.06E.

0252, 3550-0207-0179, 3550-1106-0147, 3550-1106-0148

Proultra Surgical Endo Tip

A) Alaris PC Unit

Dentsply Tulsa Dental Specialties Trading As Dentsply EndodonticsCardinal Health 303, Inc.

2009-05-11

2009-05-11

2009-04-06

2009-03-10

48008

47844

Type III

Type III

PUSURG1

A) 8015

121808304

A) >1000 Numbers, Contact Manufacturer

Prototype tips were mistakenly distributed to customers.

Potential risk when the Alaris PCA Module is used with the Alaris PC Unit. The Alaris PCA B) Alaris PCA Module

Acuson X300 PE Swiftlink Siemens Medical Solutions USA, Inc. 2009-05-11 2009-04-07 47911 Type III

B) 8120

10348531

B) >1000 Numbers, Contact Manufacturer

313288, 313171, 313273

Module can potentially infuse above or below the intended infusion dose for a specific sequence of events.Swiftlink adapters manufactured prior to October 2008 can cause a failure that results in

A) Discovery X-Ray Bone DensitometerB) Explorer X-Ray Bone Densitometer

Hologic, Inc. 2009-05-11 2009-04-17 47998 Type II A) DISCOVERY-A, DISCOVERY-C, DISCOVERY-CI, DISCOVERY-W,

A) S/N: 83232, 83336, 83760, 83792, 83024, 82888, 83053, 83318, 83576

image quality when using Acunav catheter transducers that does not support intra-cardiac diagnosis or procedure guidance. In rare instances, the system does not turn the x-rays off at the end of a DXA scan. The "x-ray on" indicator light remains on, but an audible signal and the computer screen indicate the x-ray is off.

DISCOVERY-WIB) EXPLORER

B) SN 91129

Lifepak 12 Defibrillator / Monitor Physio-Control, Inc. 2009-05-11 2009-04-09 48000 Type II LP 12 >10 Numbers, Contact Manufacturer Affected defibrillator /monitors may have a solder defect on the H bridge component that

Focal Software CDWasher Didinfector Getinge 9027 - 9100

Computerized Medical SystemsGetinge Disinfection AB

2009-05-112009-05-11

2009-04-092009-04-20

4801548035

Type IIType II

Focal SIM9027, 9100

N/AN/A

could prevent the device from providing a defibrillation shock. Setup reference point incorrectly defined for prone patients when manual shifts are used.The frame earth of the supply transformers for Getinge 9100 and 9027-series Washer

Integra CEM Premier Dental Products Company 2009-05-11 2009-03-25 48059 Type II 3001410 All Lots

Disinfector have burnt out. Result from investigation shows poor connection between incoming and outgoing Protective Earth.Sale or distribution of the Integra CEM (item #3001410) is in violation of the medical

A) E300 Corneal Topographer

DBA Premier Medical

Medmont PTY Ltd. 2009-05-11 2009-03-10 45746 Type II A) N/A A) >10 Numbers, Contact Manufacturer

devices regulations. The Integra CEM is not licensed as required per section 26 of the medical devices regulations.Unlicensed class II medical device.

B) DV2000 Digital Imaging SoftwareC) M700 Automated PerimeterQuickie LXI Manual Wheelchair Sunrise Mobility Products Division 2009-05-11 2009-02-02 47380 Type II

B) N/AC) M700LXI

B) >10 Numbers, Contact ManufacturerC) >10 Numbers, Contact ManufacturerLXI-034741, LXI-034609, LXI-034740, LXI- Stabilizer bar was inadvertently omitted from the configuration due to a system error.

Gallileo Echo Blood Bank Analyzer Immucor Inc. 2009-05-11 2009-04-02 47888 Type II 87000

034500

N/A

Stabilizer bar adds rigidity to the back to reduce head movement should the chair be involved in a vehicular collision. Incorrect patient demographic information could be associated with a sample ID. This only occurs when manually ordering an assay using the run test wizard on instrument with bi-directional interface capability.

Infinity Glucose Hexokinase Reagent

Acuson S2000

Fisher Diagnostics, A Division Of Fisher Scientific CO, LLC

Siemens Medical Solutions USA, Inc.

2009-05-11

2009-05-11

2009-04-09

2009-04-14

47989

48076

Type II

Type III

TR15498

10041461

V28015

200252, 200926, 200979, 200995

Failure of product to meet the stated performance specifications for shelf life, resulting in linearity of less than the stated specifications.When performing a tee exam with the V5MS Transducer, CW (continuous wave) mode is

SmartMonitor 2 Infant Apnea Monitor Respironics Inc. 2009-05-11 2009-04-27 48114 Type II 4002, 4003 S/N: 3000033364 to 3000038740

not functional. A waveform signal cannot be detected. This event occurs on every attempt to acquire a CW signal. A variation in the monitor manufacturing process could expose wires to potential short circuit

Insight Rev H Software-GI Motility System Sandhill Scientific Inc. 2009-05-25 2009-02-23 47672 Type III S98-1925-2H All Lots

of the wire leading to the alarm module. This can result in a situation where the alarm will not sound. In HRIM or EFT, patients with non-transmitted esophageal contractions that have been

Medline Penrose Drain Medline Industries Inc. 2009-05-25 2009-04-21 48072 Type II DYND50420, DYND50421, DYND50422, 05AA0001-09CA9999

acquired with this software, the report may incorrectly report the esophageal contraction results. A drain placed by a surgeon and an x-ray ordered, the drain did not show up on x-ray

Acuson S2000 VA10 Siemens Medical Solutions USA, Inc. 2009-05-25 2009-04-14 48077 Type II

DYND50423, DYND50424, DYND50425, DYND5042610041461 200334, 200288

although the packaging states the product is x-ray opaque. Two lots of product are affected in this issue. A series of events could cause the last image to be stored with the next new patient

VGM 19" Monitor Viewsonic Corporation 2009-05-25 2009-04-21 48079 Type II VG930M S/NS > QC2082880001

performed, L Teslia Mass 2 measurement label appears in the report in English only, more than 4 measurements may print.48 complaints reporting that the monitors lost power unexpectedly or when they attempted

00-4450-058-00, 00-4450-063-00 56454692, 70193000, 70205400

requiring more force and potentially heating the bone surface during operation.

Derma Prene Ultra Surgical Glove Ansell Healthcare Products LLC 2009-05-25 2009-05-04 48229 Type II 851365, 851470 0810006605, 0810006705 Some gloves may be discoloured as a result of film degradation. This degradation results in

CADD-SOLIS Rechargeable Battery Pack Smiths Medical MD Inc. 2009-05-25 2009-04-30 48233 Type III 21-2160-51 >10 Numbers, Contact Manufacturer

film strength properties below the ASTM performance standard for surgeon's gloves.

Reports received that when the battery pack is first installed in pump, the pump will not

A) Acuson Sequoia 512 Ultrasound SystemB) Acuson Sequoia C512 Echocardiography SystemC) Acuson Sequoia C512 Echocardiography System

Siemens Medical Solutions USA, Inc. 2009-05-25 2009-04-02 47909 Type III A) 82 45 875B) 8255412, 8267697C) 10038242

A) 53736, 54558, 55331, 61377, 63210B) 53418, 57395C) 68153, 68211, 68217, 68328, 68330, 68335,

power up or an alarm sounds and an error message displays indicating that battery pack is unusable and pump will not run. To inform our customers of a potential software problem with the Acuson Sequoia Ultrasound System that may result in overheating of the auxiliary 2 mHz continuous wave (CW) transducer.

D) Acuson Sequoia 512 Ultrasound

Accu-Chek Spirit Insulin Pump Disetronic Medical Systems AG 2009-05-25 2009-04-17 48163 Type II

D) 10038241

04540492001, 04759702001,

68365, 68366, 68368, 69281, 69291D) 68444, 65685SN02053575 to SN10006093 The insulin pump (numbers SN02053575 - SN10006093) may fail. This failure may present

Nexcare Opticlude Orthoptic Eye Patch 3M Canada Company 2009-05-25 2009-05-05 48185 Type III

04759729001

1539 900605, 902007, 902106

an intermittent or complete loss of function of the up and/or down buttons and in turn affect the desired pump operation.The primary boxes from these affected lots may not have the application instructions and

Waste Bottle For ABL7XX And 8XX Flex Radiometer Medical APS 2009-05-25 2009-04-30 48225 Type II D512 (905-590), D513 (905-802) For 905-590/D512 : WR-01, WR-02, WR-03, WS-01, WS-02, WS-03, WU-02, WU-03For 905-802/D513 : WR-01, WR-02, WR-03, WR-04, WS-01, WS-02, WS-03, WS-04, WU-

caution statements printed on the inside flaps of the primary box, as otherwise indicated.

When removing the waste bottle from the analyzer, waste material may leak both from the analyzer and from the waste bottle. This leakage is due to clogged vent holes creating over pressure in the bottle.

A) Symbia T/T2/T6/T16 Siemens Medical Solutions USA, Inc. 2009-05-25 2009-03-04 47070 Type III A) 08717733, 10275007, 10275008,

01, WU-02, WU-03, WU-04, WU-05, WU-06, WY-01 A) 1103, 1128, 1150, 1153, 1193, 1199, 1018, Possibility a patient injury can occur when the patient is lying on the patient bed and the

B) Symbia S

PSM with Validation Module

Molecular Imaging Group

Roche Diagnostics Ltd 2009-05-25 2009-04-30 47890 Type II

10275009, 10275010B) 0871774103009696001, 03265439001

1026, 1058, 1056, 1024, 1012 B) 1143, 1112, 1159>10 Numbers, Contact Manufacturer

automatic collimator changer is undergoing a collimator change operation even when the patient bed is retracted.Potential situation where the test validation ranges configured in the process systems

A) Artiste Syngo RT Therapist Assist Siemens Medical Solutions USA, Inc. 2009-05-25 2009-04-21 48254 Type III A) 08162807 A) 10024

managers (PSM) can incorrectly release a patient result where there are multiple reference ranges defined. When all plans are loaded on the device, if the beam plan is edited, accessory information in the

B) Artiste Syngo RT Therapist Oncology Care Systems B) 08162815 B) 10040 lantis can be potentially overwritten or removed, could result in mistreatment on another linear accelerator.

A) Tilt/Elevating Seating SystemB) Tilt/Elevate/Recline Seating System

Motion Concepts LP 2009-05-25 2009-02-19 46283 Type II A) N/AB) N/A

A) >10 Numbers, Contact ManufacturerB) >10 Numbers, Contact Manufacturer

Possibility of stress related cracks occurring in our power elevating seat actuator models as the result of atypical or extreme usage of the wheelchair seating system.

Kinedx 4.2 SPF Reporting Workstation Siemens Medical Solutions USA, Inc. 2009-05-25 2009-02-05 46559 Type III N/A 92172-1 Under certain circumstances, when editing text in a report, it may result in additional phrases not populating as expected.

Orthos CM Bracket

Syngo Dynamics Server Software

Ormco Corporation

Siemens Medical Solutions USA, Inc.

2009-05-25

2009-05-25

2009-02-13

2009-03-04

46601

47064

Type III

Type III

454-0210, 454-1210

100 90 480

08H599H, 08H358H, 08J174J, 08J175J

>10 Numbers, Contact Manufacturer

Orthos CM Brackets are incorrectly labelled +9 degrees, but they have a torque of -9. Attachment will result in significant delay in treatment. There is potential issue in the Syngo Dynamics 5.1 reporting system. Under certain

Syngo Imaging Update Package VB30A_HF26 Siemens AG 2009-05-25 2009-03-04 47067 Type III 10 014 063 1094, 01200

circumstances, when editing text in a report, it may result in additional phrases not populating as expected. Due to several root causes leading to missing or mislinked Performed Procedure Step's some or all studies of a patient may become inaccessible from Syngo studio. With a 3rd party RIS, sometimes "study merge" does not work.

Pneumo Sure XL High Flow Insufflator09-0142, Dean Scissors

Stryker EndoscopyWalter Lorenz Surgical, Inc. Also Trading As: Biomet Microfixation

2009-05-252009-05-25

2009-01-082009-04-02

4598347701

Type IIType II

620-040-600, 620-040-61009-0142

0804CE394 to 0810CE295>10 Numbers, Contact Manufacturer

Insufflators are powering off during surgery or not powering up completely.The 09-0142, Dean Scissors are breaking when used.

Roche/Hitachi Acetaminophen Assay

Triathlon Offset Adaptor Trials

Roche Diagnostics GMBH

Howmedica Osteonics Corporation

2009-05-25

2009-05-25

2009-05-01

2009-04-22

48042

48074

Type III

Type III

3255379190

5570-T-020, 5570-T-040, 5570-T-060,

All Lot Numbers

N/A

The claim for significant bilirubin interference decreases from 28 mg/dl (478.8 µmol/l) to 20 mg/dl (342 µmol/l) icterus index for the Roche/Hitachi acetaminophen assay.Advisory reiterating to customers the potential for the adaptor trial to seize, the preventive

5570-T-080 maintenance measures, and risk mitigation measures, as stated in the package insert.

A) Nexgen LPSB) Nexgen LPS-Flex Femoral Components

Zimmer Inc. 2009-05-25 2009-04-23 48206 Type II A) 00-5964-014-51, 00-5964-017-51B) 00599601451

A) 61219714, 61204820B) 61207901

These items may possess a nonconforming finish on the polished surfaces which could potentially increase wear and decrease the product life cycle on the articulated surface.

Austin Moore Stems - Curved 43 mm Howmedica Osteonics - Stryker Ireland 2009-05-25 2009-04-27 48207 Type II 6939-0-430 LOIINRA A size 43mm Austin Moore endoprosthesis curved stem was found packaged as a size 45mm stem.

i-STAT 1 Analyzer System-Instrument

A) Zenith Renu AAA Converter

Abbott Point Of Care Inc.

Cook, Inc.

2009-05-25

2009-05-25

2009-04-27

2009-03-16

48245

47349

Type II

Type II

06F16-10

A) N/A

>100 Numbers, Contact Manufacturer

A) All Lots

The rechargeable battery pack can overheat with or without the presence of smoke causing the Martel printer to overheat in the i-STAT 1 analyzer system.In rare cases the trigger wire can become damaged and then compressed between the stent

B) Zenith Renu AAA Main BodyC) Zenith AAA Main Body Bifurcated Stent

B) N/AC) N/A

B) All LotsC) All Lots

and the top cap, making it difficult to remove.

Terumo Advanced Perfusion System 1 Terumo Cardiovascular Systems Corp. 2009-06-08 2009-01-12 46050 Type II 801763 0013, 0017, 0020, 0021, 0144, 0193, 0396, 0601 Screws in the power manager board may come loose and come into contact with system 1 chassis.

Advance Perfusion System 1

Galileo Echo Blood Bank Analyzer

Terumo Cardiovascular Systems Corp.

Immucor Inc.

2009-06-08

2009-06-08

2009-01-29

2009-04-27

46444

48195

Type II

Type II

802100

87000

31, 39, 55, 93, 219, 220, 263, 279, 584

N/A

Poor or intermittent connections. A non functioning CCM could potentially cause the user to operate pumps using local pump controls. Improvements of Echo software since the 1.1.2.28.1, to address the recalls previously initiated: duplicate alphabetical sample barcodes, information for instruments interfaced to laboratory information system.

Folate III Reagent Kit

TransFx Drill Bit

Roche Diagnostics GMBH

Zimmer Inc.

2009-06-08

2009-06-08

2009-05-08

2009-05-06

48241

48337

Type III

Type II

4476433190

00-4450-054-00, 00-4450-056-00,

15068201, 15127201

56454683, 70196100, 70185600, 70221300,

Certain lots of the Folate III Reagent Kit may induce an elevated recovery of folate in li-heparin plasma. Device possesses non-conforming tip geometry, reducing the efficiency of drilling action,

SSR203, SSR303, SSR306, SVDD303, SVVI103

with interconnect wire separation caused by a particular cleaning solvent used in manufacturing.

A) Pumps/Sequential CirculatorsB) BioComfort Arm GarmentsC) BioComfort Leg Garments

Bio Compression Systems 2009-06-08 2009-05-11 48425 Type III A) SC-2004, SC-3004, SC-3008B) GS-3035-M, GS-3035-SC) GS-3045-H, GS-3045-L, GS-3045-M,

A) N/AB) N/AC) N/A

Medical devices sold in Canada by Bio Compression Systems are not licenced in accordance with the medical devices regulations.

GS-3045-S

XIO Radiation Treatment Planning System Computerized Medical Systems 2009-06-08 2009-05-05 48447 Type II N/A Versions 4.3.0 to 4.40.0 When beams are renumbered, it is possible to get into a state where the dose displayed for a beam does not match the beam placement on the patient.

TM-400 Broach Handle

Definition AS

Zimmer Trabecular Metal Technology, Inc.

Siemens AG

2009-06-08

2009-06-08

2009-05-08

2009-02-25

48453

48470

Type II

Type III

96-210-10001

8098027

All Lots

64238, 64032, 64049, 64052, 64069, 64137,

Device may fracture at the threaded tip during use, leaving the broach or trial in the surgical site.This update instruction provides improved fixation of the telescope support.

64141, 64233, 64306, 64316, 64362

Custom-Pak Opthalmic Surgery Pak Alcon Laboratories Inc. 2009-06-08 2009-05-01 48472 Type II 13305-01 894213H Identification of oxidization on some of the 25GA Trocar Blades packaged in the 25GA Total Plus paks which are part of the Alcon custom-pak procedure pack.

AW Volumeshare2 - Software Options

A) Precicontrol Cardiac

GE Healthcare

Roche Diagnostics GMBH

2009-06-08

2009-06-08

2009-04-21

2009-03-26

45984

47413

Type II

Type III

B79011MA

A) 03530477190

S/N'S 96090GE6, 96091GE4, 98606GE7, 98607GE5, 98608GE3A) N/A

Under certain conditions, the series could be incorrectly labelled in image view, which could lead to under-treatment of a tumour.Potential for precision issue with the Elecsys Cardiac and Cardiac II. Specifications for the

B) Precicontrol Cardiac II

A) Vacora Vacuum Biopsy SystemB) Vacora Vacuum Biopsy System - Cannula

Bard Peripheral Vascular, Inc. 2009-06-08 2009-04-14 47925 Type II

B) 04917049190

A) VC10118PB) VC10118MR

B) N/A

A) HUSA1668, HUSC1533, HUSD1075, HUSI1063, HUSG0594

intra-assay precision was not met independent of the Elecsys Digoxin Reagent or Precicontrol lot used.Some Vacora 10g plastic coaxial cannulas may leave a small metal filament in the breast.

Lifepak 9/9P Internal Paddles & Handles Physio-Control, Inc. 2009-06-08 2009-02-17 48161 Type II 11130-0000XX, 11131-0000XX, 800441-

B) HUSH0816, HUSI0216, HUSC1588, HUSD2647> 10, Contact Manufacturer Sterilization efficacy for the current labelled methods cannot be confirmed. These Lifepak

A) MANTIS Rod Inserter Stryker Spine SAS 2009-06-08 2009-04-28 48210 Type II

XX, 802154-XX

A) 48284050 A) All Lot Numbers

9/9P internal defibrillation handles without discharge control & custom-mated paddles, were discontinued in August 2008. The stainless steel split sphere in the Mantis Rod Inserter Shaft has the potential to become

B) MANTIS Rod Inserter Inner Shaft

Advia 70 Testpoint Haemotology High Con Siemens Healthcare Diagnostics Inc. 2009-06-08 2009-05-12 48471 Type III

B) 48284051

B03-4585-54

B) All Lot Numbers

TP93037

deformed when subjected to high force. Once deformed, the split sphere may separate from the shaft. Complaints that the Percent Eosinophils (EOS) is not recovering within the range specified

Acist Angiographic System-Manifold Kit Acist Medical Systems Inc. 2009-06-08 2009-05-13 48480 Type II BT2000 3168H

for lot TP93037 of testpoint high control. The supplier confirmed a value assignment error for this lot.The manufacturer has received field reports of a bulge and leaks on the side of the 2.5" high-pressure tubing of BT2000 kits during a procedure which can result in unsatisfactory performance of the product.

Insufflation Tubing With Filter

SmartMonitor 2 Infant Apnea Monitor

Medovations Inc.

Respironics Inc.

2009-06-08

2009-06-08

2009-05-14

2009-04-27

48488

48114

Type II

Type I

SU1101

4002, 4003

209296

S/N: 3000033364 to 3000038740

The device, model SU1101, is not licensed for sale in Canada. It is however the same product in specifications and materials as JA-1101, which is licensed for sale in Canada.A variation in the monitor manufacturing process could expose wires to potential short circuit

Updated recall # 48114 previously posted on 2009- of the wire leading to the alarm module. This can result in a situation where the alarm will 05-11. Preciset TDM I / Preciset TDM II Roche Diagnostics GMBH 2009-06-08 2009-05-12 48228 Type III 03375781190, 03375790190 15617400 & 15612200, 15612300

not sound. Bottle caps are being too difficult to remove.

Vertier Table Headrest Attachment

Cypher Select + Sirolimus-Eluting Stent

Stryker Communications

Cordis Europa N.V.

2009-06-08

2009-06-08

2009-05-15

2009-05-08

48498

48561

Type II

Type III

0788-300-012

CRB08225, CRB08250, CRB08275, CRB08300, CRB08350, CRB13225, CRB13250, CRB13275, CRB13300, CRB13350, CRB18225, CRB18250, CRB18275, CRB18300, CRB18350, CRB23225, CRB23250, CRB23275, CRB23300, CRB23350, CRB28225, CRB28250, CRB28275, CRB28300,

All Lot Numbers

>100 Lots, Contact Manufacturer

The headrest has two pinch points that could result in hospital staff injury during the transportation of the headrest when it is detached from the table.In response to an increased number of complaints of cracks in the balloon inflation port hub of this coronary stent, a field safety notice has been issued to remind users to follow inspection and preparation steps.

Human STFR Quantikine IVD Kit R & D Systems, Inc. 2009-06-08 2009-03-03 48601 Type II

CRB28350, CRB33225, CRB33250, CRB33275, CRB33300, CRB33350N/A 259416, 261514, 262759 During manufacturing, it was found the standard used to calibrate the assay, may have

Quantikine IVD Human B2-Microglobulin R & D Systems, Inc. 2009-06-08 2009-03-04 48674 Type II N/A 260980

evaporated in some vials. If evaporation occurs this will cause the standards to read erroneously.During manufacturing, it was found the standard used to calibrate the assay, may have evaporated in some vials. If evaporation occurs this will cause the standards to read erroneously.

Ready Kit

A) Sigma Pacemaker SystemB) Kappa 600 KDR Series PacemakersC) Kappa 700 KDR Series PacemakersD) Kappa 700 KD Series PacemakersE) Kappa 700 KSR Series PacemakersF) Kappa 900 KSR Series Pacemakers

Cardiac Science Corporation

Medtronic Inc.

2009-06-08

2009-06-08

2009-02-10

2009-05-18

48618

48540

Type III

Type I

N/A

A) SD203, SD303, SDR203, SDR303, SDR306, SS106, SS203, SS303, SSR203, SSR303, SSR306, SVDD303, SVVI103B) KDR603C) KDR703, KDR706, KDR721D) KD701, KD703, KD706

N/A

A) >100 Lots, Contact ManufacturerB) PHH620224S, PHH620227SC) PGY623319S, PGY623323S, PGY623355S, PGW621053S, PGR625317S, PGR625959SD) >10 Lots, Contact ManufacturerE) >1000 Lots, Contact ManufacturerF) >100 Lots, Contact Manufacturer

Ready kits, part# 5550-003, contain gloves and antiseptic wipes that are not licensed in accordance with the medical devices regulations. The pacemakers may fail at a higher than expected rate due to separation of wires that connect the electronic circuit to other pacemaker components (e.g. battery, connector). This may present clinically as loss of rate response, premature battery depletion, loss of telemetry, or no output.

Sigma Pacemaker System Medtronic Inc. 2009-06-08 2009-05-18 48702 Type I

E) KSR701, KSR703, KSR706F) KSR903SD203, SD303, SDR203, SDR303, SDR306, SS106, SS203, SS303,

>1000 Lots, Contact Manufacturer This is an update of performance and patient management recommendations for a subset of Sigma pacemakers previously recalled because of an increased rate of failure associated

Alumina Ceramic Femoral Head Zimmer Inc. 2009-06-22 2009-06-01 48988 Type II 00-6428-032-02 61007046 Some units in this lot may have the inner tyvek peel tab trapped within the outer seal. This configuration could result in delamination of the inner tyvek seal as the package is opened, complicating removal of the implant from the package while maintaining sterility.

A) Multidiagnost Eleva-Flat DetectorB) Allura XPER FD10/10-Main Unit

Philips Medical Systems Nederland B.V. 2009-06-22 2009-05-15 48595 Type II A) 70834B) ALLURA XPER FD10/10

A) N/AB) N/A

The system may shut down and not restart due to a manufacturing error in the printed circuit board in the main-cabinet.

Architect Reaction Vessel

Chemiluminescent Substrate

Abbott Laboratories Diagnostic Division

Siemens Healthcare Diagnostics Inc.

2009-06-22

2009-06-22

2009-05-19

2009-05-06

48605

48608

Type II

Type III

7C15-01

L2SUBX

> 10 Numbers, Contact Manufactuer

253, 254

Reaction vessels made from specific lots of resin had an increased likelihood of producing error code 1006 and error code 1007 and incorrect/elevated results.Complaints received regarding substrate l2subx lots 253 and 254, which may affect the

A) Vitros 3600 Immunodiagnostic SoftwareB) Vitros 5600 Integrated System Software

Ortho-Clinical Diagnostics Inc. 2009-06-22 2009-05-28 48864 Type II A) 680 2865B) 680 2863

A) 36000116, 36000130B) 56000193, 56000298, 56000124, 56000136,

performance of the Immulite 2000 and Immulite 2500 assays. These substrate lots may introduce a shift in both quality control and patient results. Complaint received of a biassed glucose result on a Vitros 5600 Integrated System. Investigation has found that under a very specific set of circumstances, when the

Prelude Short Sheath Introducer Merit Medical Systems Inc. 2009-06-22 2009-04-20 48882 Type II PSS-5F-4-018MT, PSS-5F-4-038MT,

56000336, 56000337

N/A

display/report screen is configured by the operator, an erroneous result could also be generated by the Vitros 3600 Immunodiagnostic System. The sidearm tubing may detach from the sheath during use. If this failure occurs, it may

PSS-5F-4MT, PSS-6F-4-018MT, PSS-6F-4MT, PSS-7F-4MT, PSS-8F-4MT

result in excessive patient blood loss and/or risk of blood-borne pathogen exposure to those in the surrounding area.

VS Ventilator

A) Wiseguide Guide Catheter FemoralB) Wiseguide Guide Catheter AllrightC) Wiseguide Guide Catheter VodaD) Wiseguide Guide Catheter AmplatzE) Wiseguide Guide Catheter BypassF) Wiseguide Guide Catheter MultipurposeG) Wiseguide Guide Catheter RadialH) Wiseguide Guide Catheter Kimny

Resmed Paris

Medi-Tech Boston Scientific Corporation

2009-06-22

2009-06-22

2009-06-01

2009-03-13

48885

47359

Type III

Type III

N/A

A) 16320-02, 19500-02, 19500-29, 19815-92, H74919815520B) 19815-501C) 16320-72, 16320-78, 19500-71, 19500-72, 19500-73, 19500-74, 19500-77, 19500-78, 19815-71, 19815-72, 19815-73, 19815-74D) 16320-17, 16320-18, 16320-20, 16320-21, 19500-20, 19500-21, 19500-22E) 19815-446F) 16320-141, 19500-39, 19815-41G) 19815-554H) 19815-583

VSU0802002, VSU0802003, VSU0802001, VSU0711510A) H74916320021, H74919500020, H74919500290, H74919815920B) H749198155010C) H74916320721, H74916320781, H74919500710, H74919500720, H74919500730, H74919500740, H74919500770, H74919500780, H74919815710, H74919815720, H74919815730, H74919815740D) H74916320171, H74916320181, H74916320201, H74916320211, H74919500210, H74919500220, E) H749198154460F) H749163201411, H74919500390, H74919815410G) H749198155540

Resmed received a report of a failure of a VS Ventilator in Japan that had resulted in a failure of ventilation at start-up. It occurred within a hospital environment. Difficulties in connecting the product hubs with the Y-adaptors and toughy borst connectors. Product out of specs with thread outer diameters.

PFC Sigma CR Non-Porous Left Femoral Depuy Orthpaedics, Inc. 2009-06-22 2009-05-29 48935 Type II 960005

H) H749198155830

2843263, 2869123, 2845534, 2845530, 2844799, 2952392, 2852394, 2842528,

A small number of PFC Sigma Cruciate Retaining Non-Porous size 5 left femoral cemented components within the affected lots have been identified as having a microscopic crack on

2844381, 2843270, 2843268 the lateral side of the condyle in the posterior chamfer region. Microscopic cracks have the potential to affect the performance of the implant.

Disposable Endoscopic Surgery Blades

Steris CMAX Surgical Table Hand Control

Smith & Nephew, Inc., Endoscopy Division

Steris Corporation

2009-06-22

2009-06-22

2009-05-08

2009-05-22

48408

48912

Type II

Type III

7206010, 7206011, 7210499

N/A

20148707, 20148714, 20153849, 20153865, 20154971AC001 TO AC0221

There is the potential for a compromised sterile barrier in the tyvek lid of the primary packaging. A limited quantity of the CMAX Hand Controls were manufactured without loctite thread locker on the screws that attach the mounting clip to the hand control case. It is possible that screws without the loctite can work loose and the clip can become separated from the hand control. If both screws back out completely, the internal components of the hand control

A) Picis OR ManagerB) Picis Preop ManagerC) Picis Anesthesia Manager

Picis Inc. 2009-06-22 2009-04-08 48937 Type II A) model/catalog # 4235B) model/catalog # 4250C) model/catalog # 4220

A) N/AB) N/AC) N/A

and/or the table control board may become damaged. This could cause a loss of hand functionality.If not properly configured, software will allow patient allergy and precaution data to be overwritten with automatic updates from the hospital information system (HIS). This can result in deletion of allergy information.

D) Picis PACU ManagerE) Picis Critical Care ManagerInstrument Manager Data Innovations 2009-06-22 2009-05-11 48997 Type II

D) model/catalog # 4245E) model/catalog # 1110IM-B02V8.06, IM-B02V8.07, IM-

D) N/AE) N/AN/A The previous results retrieved from the specimen management database, which may be

B02V8.08, used by rules, may not be the most recent previous version.

BD Falcon 100X20 mm Tissue Culture Becton, Dickinson And Company 2009-06-22 2009-02-17 47220 Type IIIIM-B02V8.09N/A > 10 Numbers, Contact Manufactuer Dishes containing a small crack, which may result in the leakage of cell culture media during

incubation. This crack is located on the bottom of the dish along the stacking ring.Washer Disinfectors With Transformer

ASC 2000 Ambulatory Surgical Table

Getinge Disinfection AB

Mediland Enterprise Corporation

2009-06-22

2009-06-22

2009-04-24

2009-04-17

48035

48613

Type II

Type III

9027, 9100

MTS110003

> 10 Numbers, Contact Manufactuer

07160407V3.01, 043600401V200, 043600402V200, 041600323V200,

The frame earth of the supply transformers for the Getinge 9100-series Washer Disinfector have burnt out on one installation in Australia. Repetitive rubbing of the hydraulic hoses against the interior of the stainless steel shroud may result in the rupture of the hydraulic hosing causing loss of control of the table surface.

045100705V300, 061400907V3.00, 061406905V300

Dyonics 25 Tube Set Kits

Compax 40E Table

Smith & Nephew, Inc., Endoscopy Division

GE Healthcare

2009-06-22

2009-06-22

2009-05-29

2009-02-18

48968

45258

Type II

Type II

7211005, 7211006

N/A

> 10 Numbers, Contact Manufactuer

> 10 Numbers, Contact Manufactuer

The material thickness of the trays used for packaging the tube sets may not be sufficient to maintain the sterile barrier. Table locks may not actuate, causing tabletop to unexpectedly float in either of the following axes: 1) lateral axes, 2) bidirectional (longitudinal and lateral) axes, which could injure patient or user.

ZMR Hip System-Stems Zimmer Inc. 2009-06-22 2009-05-27 48913 Type II 00-9982-015-18 60698102 The stem threads on some units in this lot may be nonconforming, preventing the compression nut from engaging on the stem.

2.7mm Cortical Screw Self-Tapping Zimmer Inc. 2009-06-22 2009-06-01 48914 Type II 00-4827-024-01 60886890 The 2.7mm Cortical Screw Self-Tapping package could potentially hold the 4.0mm cancellous screw partially threaded (part number 00-4840-022-01).

B) Advia Centaur XP B) 07566733 B) > 10, Contact Manufacturer negative populations. The positive bias of approximately 0.3 index units and specimens with 0.5 to 0.8 index may be incorrectly identified as reactive for total antibodies to the core antigen of Hepatitis B virus.

A) Integris V5000/BV5000B) Integris H5000F Cardiology Imaging SystemC) Integris H5000C Cardiology Imaging SystemD) Integris BH5000 Cardiology Imaging SystemE) Integris AlluraF) Allura XPER FD10

Philips Medical Systems Nederland B.V. 2009-06-22 2009-05-12 49048 Type II A) 722041*, 722042*B) 722017C) 722016D) 722021E) 722043*, 722044*F) ALLURA XPER FD10

A) N/AB) N/AC) N/AD) N/AE) N/AF) N/A

A partial grid switch failure may occur in Allura XPER and Integris systems that may result in a higher x-ray dose than expected. This issue may pose a risk for patients or users. The potential failure can lead to a radiation exposure rate in excess of the 11.5 R/min Health Canada requirement. However, it will only occur if the grid switch fails during fluoroscopy examinations using high KV values.

G) Integris H1000 H) Integris H3000

G) N/AH) N/A

G) N/AH) N/A

I) Integris V3000Carescape V100 GE Medical Systems Information Technologies 2009-06-22 2009-02-09 46236 Type II

I) N/AV100-QBAA-CXAA-XX

I) N/A> 10 Numbers, Contact Manufactuer The alarm and pulse volume indicators are inverted on the label of french language units.

Muse Cardiology Information System GE Healthcare 2009-06-22 2009-03-04 46833 Type II MUSESW7-XXXXXXXX > 10 Numbers, Contact Manufactuer Stored and printed records may contain incorrect information when records containing default patient identifiers (PID) are confirmed as valid PID's in Muse Cardiology Information Systems versions 7.0, 7.01, 7.0.2, 7.1 & 7.1.1

CIC Pro Clinical Information Center GE Healthcare 2009-06-22 2009-02-19 46853 Type II CIC-XXXX-XXXXX-XXXXX* S/N'S SDY09020430GA & SDY09030443GA Circuit board supplied by 3rd party for MP 100 hardware platform for CIC Pro version 5.1 software may fail and result in potential loss of monitoring and inability to power up after

Hinged Knee Brace

Intellivue MP70 Patient Monitor System

Trainer's Choice

Philips Medizin Systeme Boeblingen GMBH

2009-06-22

2009-06-22

2009-01-07

2009-05-22

48389

48839

Type III

Type II

101

M8007A

8-31313-00003-2, 8-31313-00004-9, 8-31313-00002-5N/A

powering down of CIC Pro. Evidence of mold was found on the leather pieces on the outside of the braces. Product integrity and effectiveness was not affected. If scheduled orders are documented and edited prior to the orders' original schedule time, Carevue Chart Release C.0 (running on the DC7100 computers of the Intellivue MP700 patient monitor system) can create a second instance of the same order marked as pending, if the following conditions occur:1. An order or intervention is entered as a scheduled administration and 2. A clinician charts the pending order earlier than scheduled and3. A user/clinician changes, edits or acknowledges the �

Sireskop SX/SD Siemens AG 2009-06-22 2009-02-11 47071 Type III 10093754, 31 11 676, 3111668 21005, 21040, 21087, 21107, 21110, 31036, 34170, 36103, 41021

A defective behaviour in data transport layer of the network file system (NFS) connection could cause series as marked successfully archived even though the content is saved sporadically with defective pixel or header data.

1.5T Signa Infinity MR Excite - System

Posey BuckleErytype S RH Donor Plates

GE Healthcare

J T Posey Co.Biotest Medical Diagnostics GMBH

2009-06-22

2009-06-222009-06-22

2009-05-11

2009-05-292009-04-03

47837

4889949138

Type II

Type IIIType III

2294302, M3000CB

N/A806190100

> 10 Numbers, Contact Manufactuer

235018, 235036, S27947, S279577839010, 7910010

An error in the coding of the 11.1_M4_0818A version of software can result in images being flipped under very limited and specific conditions. Product made with incorrect buckle, potential for failure.One lot of Erytype S RH Donor Plates contains an error in the labelling on the foil packet.

Aria Radiation Oncology Varian Medical Systems, Inc. 2009-06-22 2009-05-08 49074 Type II 8.1.15, 8.5.11, 8.6.07, HIT > 10 Numbers, Contact Manufactuer

The product is correctly identified, however the product description immediately below is incorrectly stated. The outer box information is correct as well as the barcode information on the plate frames and microplate strips. Software anomaly leads to a record save fail in the case that a partially treated fraction has zero dose accumulation. If the change to the plan had been to parameters other than dose per fraction, treatment to incorrect volume could result, potentially leading to serious injury.

A) Achieva 3.0T MRI System-Main UnitB) Achieva 1.5T MRI System-Main UnitA) Avalon Fetal Monitor FM30-Main UnitB) Avalon Fetal Monitor FM20-Main Unit

Philips Medical Systems Nederland B.V.

Philips Medizin Systeme Boeblingen GMBH

2009-06-22

2009-06-22

2009-06-09

2009-06-09

49149

49150

Type II

Type II

A) ACHIEVA 3.0TB) ACHIEVA 1.5T A) M2703AB) M2702A

A) N/AB) N/A A) DE53001002 Through DE53107383B) DE53001002 Through DE53107383

The affected MR accessory carts may contain magnetic material and can therefore be attracted to the magnet. This problem affects revision C and D of the software. In rare circumstances, the settings for paper scale type and recorder speed may revert back to the factory default settings, which are: USA paper style and 3 cm/min paper speed. This behaviour would have the most impact in Europe and Asia/Pacific where other settings are preferred. If this change remains undetected by the user, it may lead to misinterpretation of the fetal trace and potential incorrect clinical decisions regarding patient care. The problem occurs when the power-

Brilliance 6/10/16 Slice CT-SFRTWR Dent Philips Medical Systems (Cleveland), Inc. 2009-06-22 2009-06-10 49151 Type II 455011202691 N/A

up/boot sequence of the fetal monitor is interrupted, e.g. switching the monitor off or unplugging the power cord before it has completed the boot sequence and switching it on again immediately (within 60 sec) after the interruption. 1. When images are saved or filmed that contain the curved multi_planar reformation

A) System 1000 Dialsate Delivery System - AuroraB) System 1000 Dialsate Delivery System - TinaC) Arena SPP Hemodialysis Delivery SystemD) Arena SPX Hemodialysis Delivery System

Baxter Healthcare Corporation 2009-07-06 2009-04-09 47924 Type III A) SYS1000-L3DPHA, SYS1000-L3P, SYS1000-L3PA, SYS1000-L3PHAB) SYS1000-L3DPHA, SYS1000-L3P, SYS1000-L3PA, SYS1000-L3PH,

A) All LotsB) All LotsC) All LotsD) All Lots

section (CMPRS) while using the dental application v4.0.0 to v4.0.1.9999 on the extended brilliance workspace, the right/left annotations will be reversed on views that were created with a short curve. An Arena instrument set to deliver 50 ml/min. may deliver between 40 & 60 ml/min., contrary to operator and service manuals. Sys1000 manuals do not specify blood flow accuracy as required by IEC standard.

SYS1000-L3PHA, SYS1000-L3PHDPC) ARENASPP-DH, ARENASPP-HD) ARENASPX-BDH, ARENASPX-HR

A) Isolex 300I Magnetic Cell SeparatorB) Isolex 300 Magnetic Cell Separator

Baxter Healthcare Corporation 2009-07-06 2009-05-04 48344 Type II A) 4R9734B) 4R9734

A) All LotsB) All Lots

HSA used to produce this reagent does not comply with the USP monograph as per what the current labelling and package inserts state. It complies with European pharmacopeia instead.

Stat G3+ Cartridges Abbott Point Of Care Inc. 2009-07-06 2009-05-12 48497 Type II 06F03-01, 06F03-02 P08321C Box numbers 1491 and 1534 of this device from lot # P083221C have suboptimal pouch

LCT-1000 Therapy LaserA) Advia Centaur

Litecure, LLCSiemens Healthcare Diagnostics Inc.

2009-07-062009-07-06

2009-05-152009-06-10

4919249196

Type IIType III

N/AA) 07566733

N/AA) > 10, Contact Manufacturer

seals. If a cartridge or suboptimal pouch seal is run, there is a possibility that the performance of the cartridge assays may be impacted. The LCT-1000 Deep Tissue Laser Therapy is an unlicenced medical device. Manufacturer has determined that specific lots have shown decreased specificity for

Dall Miles Trochanter Cable Grip System Howmedica Osteonics - Stryker Ireland 2009-07-20 2009-06-15 49278 Type II 6704-0-210 Serial # 29233201 During post-sterilization inspection of the outer blister of the affected lots, it was determined that the outer blister did not meet the required minimum seal width. (Note: the inner blister seal was not affected).

Definium 5000 Digital Radiographic System GE Healthcare 2009-07-06 2009-06-11 47773 Type II 5220493-2 GEHC00070 & GEHC00096 When configured for AEC, after first exposure terminates, subsequent exposures fail to terminate because functionality of ion chamber ramp comparator with low reference voltage is not reliable.

Chloride Membrane on ABL 700 & 800 Flex Radiometer Medical APS 2009-07-06 2009-06-05 48585 Type III 942-061 177 Composition of electrolyte solution in membrane units for the affected lot 177 are incorrect and cause the sensitivity of chloride electrode to be very low and the analyzer rejects

Delfia Xpress PAPP-A Kit Wallac OY 2009-07-06 2009-05-21 48607 Type II 6003-0020 490042, 490656, 503140, 506860, 507311, 516518

calibration. There is a decrease in the measurement of PAPP-A levels compared to previous lots, leading to the possibility of an increased false positive rate in screening programs.

Sur-Catch No Tip Nitinol Stone Basket

A) Nexgen Rotating Hinge Knee-Femoral ComponentB) Nexgen Rotating Hinge Knee-Tibial Component

Gyrus Acmi, Inc.

Zimmer Inc.

2009-07-06

2009-07-06

2009-06-04

2009-06-08

49030

49105

Type II

Type II

5711222

A) 00-5880-014-01, 00-5880-014-02, 00-5880-015-01, 00-5880-015-02, 00-5880-

89261CB, 89262CB, 91665DB, 91666DB

A) 60147327, 60230599, 60137094, 60163665, 60173203, 60144695, 60174823, 60186251,

Due to an error, some product was shipped out with a new polyamide sleeve material before the qualifying process was completed. Because of this, Gyrus ACMI cannot ensure that the product's shelf life will meet the expiration date on the label.This action is being conducted because these components are labelled with a ten year expiry period when in fact these components expire five years after manufacture.

A) Immunocap 250 Specific IGE ControlB) Immunocap 100 Specific IGE Control

Phadia AB 2009-07-06 2009-03-29 49233 Type III

016-01B) 00-5880-002-00, 00-5880-004-00, 00-5880-005-00, 00-5880-006-00A) 10-9449-01B) 10-9449-01

60141825B) 60195329, 60160461, 60203906, 60206499, 60180540, 60170823, 60191094A) BNMAX, BNMAY, BNMAZB) BNMAX, BNMAY, BNMAZ

Phadia AB, (Sweden) voluntarily recallsImmunoCAP Specific IGE Control (art.no 10-949-01) containing vial lot BNMAX, BNMAY, or BNMAZ using ImmunoCAP Allergen E1. Manufacturer updates information on target range values for one of seven ranges stated in the directions for use. Product is a control sample used by laboratory for internal quality assurance. A new range is established for ImmunoCAP Allergen E1. For some customers the results may be out of range and

Dual Offset Broach Handle Left and Right Biomet, Inc. 2009-07-06 2009-03-31 48593 Type II N/A All Lotscould result in a quality assurance investigation at the customer's site. Handle body may crack or fracture, which could puncture or rupture the skin of the patient, surgeon or attending nurse and lead to increased risk of infection.

Impression Coping Closed Tray Regular Platform 05x9mm

Nobel Biocare AB 2009-07-06 2009-05-21 48621 Type II N/A 687218 Impression Coping Closed Tray NobelActive Internal Regular Platform (RP) 05x9mm (article no. 34235, lot no. 687218) was incorrectly packaged with the larger size 06x9mm.

Flexicair

A) Cell-Dyn 1700 Analyzer/1700CS Analyzer

Hill-Rom Manufacturing, Inc.

Abbott Laboratories Diagnostic Division

2009-07-06

2009-07-06

2009-05-18

2009-06-12

49146

49223

Type II

Type III

I3000, M4000

A) 03H53-01, 03H57-01, 03H57-03

N/A

A) N/A

It is possible for the identified devices to emit smoke from the blower box assembly. Hazard of smoke inhalation and presence of smoke which can trigger smoke detection alarms.

Use of the current available version of the 10ml diluent syringe, part number (p/n) 9212368 B) Cell-Dyn 1800 Analyzer

Powersail Coronary Dilation Catheter Abbott Vascular 2009-07-06 2009-06-18 49279 Type II

B) 07H77-01

1005726-08

B) N/A

7112051

(without spacer), on a Cell-Dyn 1700, Cell-Dyn 1700cs, or Cell-Dyn 1800 with a die-cast syringe drive may result in diluent leakage during initialization of the analyzer, resulting in "diluent empty" faults.Received a report of damage to the distal shaft of the catheter. While the issue should be detected during the preparation of the product, it has the potential to cause a leak of contrast material. A leak has the potential to lead to a variety of catheter functional failures and clinical consequences as described in the instructions for use. Patients who have already been treated are not affected by this action and this action does not affect any other part

Instrument Manager Data Innovations 2009-07-06 2009-06-18 49308 Type III IM-B02 VX.XX N/Anumber or lot number of the Powersail product line. Previous results retrieved from the specimen management database, which may be used by rules, may not be the most recent previous result.

Dimension Vista System-Urea Nitrogen Assay

M3 Micro-MLC For Varian With MLC

Siemens Healthcare Diagnostics Inc.

Brainlab AG

2009-07-06

2009-07-06

2009-06-19

2009-03-19

49361

47235

Type III

Type II

K1021

41600-3, 41600-5, 41600-6

09061AA

01-006-41600, 01-044-41600, 41600-052-99, E41600-3/30793

Customer complaints received regarding inaccurate results with Dimension Vista Bun Flex Reagent Cartridge in that test results may be falsely elevated or depressed, with a variable error magnitude. Potential risk of interference when using BrainLAB M3 on a Varian Linear Accelerator with the Internal Varian Multileaf Collimator not in Park mode during treatment. The Internal Varian F-Collimator could interfere with the intended conformal fields of the BrainLAB M3 during patient treatment. This may cause a critical under-dosage of the target region.

E-Cylinder Canister Holder Stryker Communications 2009-07-20 2009-06-08 49172 Type II 0682-000-449, 0682-001-111 All Lots The older version of the device has a design defect which allows for a fatigue related failure. There are two screws that attach the cage to the bracket which may fatigue over time and fail causing the cage to become detached from the mount and fall.

Digital Radiography Imaging System

A) 0.8% Resolve Panel A Reagent RBCB) 0.8% Resolve Panel B Reagent RBC

Toshiba Medical Systems Corporation

Ortho-Clinical Diagnostics Inc.

2009-07-20

2009-07-20

2009-06-12

2009-06-11

49202

49448

Type II

Type III

TFD-3000A1/WV

A) 6902317B) 6902318

N/A

A) VRA124, VRA125, VRA126, VRA127, VRA128

In rare cases, the target image cannot be displayed or output to an external device after the system is simultaneously operated from the control room and the examination room in the Radrex-i system. OCD has received complaints from customers reporting that caps on several reagent red blood cell product vials are too tight. In some of those complaints, customers reported

C) 0.8% Resolve Panel C Reagent RBC C) 6902319 B) VRB123, VRB124, VRB125, VRB126, VRB127

breaking or cracking of the glass reagent vial while attempting to unscrew the cap prior to use.

Quinton QStress TM55 Stress Treadmill

Exogen Bone Healing System

Cardiac Science Corporation

Smith & Nephew, Inc.

2009-07-20

2009-07-20

2009-03-30

2009-06-10

49032

49177

Type II

Type II

N/A

71034101

C) VRC123, VRC125, VRC126, VRC127Serial # 11040079567, 11040079568

> 10 Numbers, Contact Manufacturer

Review of test records indicated that the two impacted TM55 Stress Treadmills may not have received adequate testing prior to being shipped from the factory. A small percentage of the devices (approximately 1%) may deliver less than the intended amount of ultrasound. This reduction in ultrasound output is the result of partial loosening of internal glued components within the small black cylindrical head, called a transducer. Reduced ultrasound output may affect the progress of patient fracture healing.

A) S3 Med/Surg Bed FowlerB) Secure II Med/Surg Bed Fowler

Stryker Medical 2009-07-20 2009-06-11 49199 Type II A) 302S3-000-000B) 3002-000-000

A) All lotsB) All lots

There is potential for the Fowlers (backrests) to drift down to the flat position on the beds. The cause of the drifting Fowler is the Fowler clutch wrapspring having the potential to entangle in between the cup and coupler of the Fowler clutch assembly.

P

estimation of velocity when using pulsatility index tool which is sensitive to noise in spectral Doppler waveform causing mis-trace, user is unaware of miscalculations.

Olympus Mobile Workstation, Transformer

Carendo Multipurpose Hygiene Chair

Keymed (Medical & Industrial Equipment) Ltd.

Arjo Hospital Equipment AB

2009-07-20

2009-07-20

2009-06-16

2009-06-16

49339

49446

Type III

Type II

MAJ-174, MH-787

BIB2003-01

Serial Numbers Less Than 2810808

> 10 Numbers, Contact Manufacturer

The fuse holder on the transformers assembled on the bottom of a number of Olympus WM Series Mobile Workstations (WM-NP1, WM-WP1, WM-DP1, WM-SC) can overheat and arc if the fuse carrier is not sufficiently tightened.A limited number of complaints have been received regarding the Carendo related to skin pinching. If the Carendo is not used in compliance with the device instructions for use. Trending has shown a number of events relating to what has been generally described as clip detachments.

BD MultiSET Software V.3.0.1 Becton, Dickinson And Company 2009-07-20 2009-06-24 49459 Type III 643347, 643437, 644459 N/A A multi-sipping issue was found in BD MultiSET Software Version 3.0.1. The software is not adjusting its acquisition criteria for some samples. It only displays the last batch of events acquired.

Genesis II Femorals

Coonrad/Morrey Total Elbow SystemLaparo-Thoraco Telescopes, Cable Unit

Smith & Nephew, Inc.

Zimmer Inc.Olympus Winter & IBE GMBH

2009-07-20

2009-07-202009-07-20

2009-06-10

2009-06-092009-06-25

49201

4936249518

Type II

Type IIType III

71420026

32-8105-038-00A50001A, A50003A, A50021A, A50023A, WA50003L

08HM17084

61249897, 61249899> 10 Numbers, Contact Manufacturer

Smith & Nephew has received complaints of lugs missing from the femorals. The missing lugs are apparent to the user upon opening of the inner sterile tray.Some units in these lots may contain a void in the side seals of the Tyvek/poly pouch.Due to a geometrical incompatibility between the light guide cable and light source the "high intensity mode" cannot be switched on. Due to a production failure of the manufacturing

Architect I System-Total B-HCG Reagent Abbott Ireland Diagnostics Division 2009-07-20 2009-06-30 49556 Type III 7K78-20, 7K78-25 74908JN00, EXP 17 DEC. 2009, 74908JN01, EX

partner, the distance between the coverglass of the light guide cable and the ledge does not meet specifications. Production between January 2009 and May 28, 2009 was affected.

Abbott has observed an increase in complaints for the following error codes when using ARCHITECT Total β-hCG Reagent with specified lots:

BHR Acetabular Cups Smith & Nephew Orthopaedics Ltd. 2009-07-20 2009-06-30 49557 Type II 74120152 (L)08CW16248

-1109 "assay (X) number (Y) calibration failure, ratio too small for CAL B/CAL A" and /or- 1005 "result cannot be calculated, final RLU read is outside the specification of the lowest calibrator". The engraving on the plastic cap does not match the outer label indications for size. The BHR Acetabular Cup and femoral head packages include labelling and colour coding to prevent mismatch in component size selection. The engraved numbers on the impactor cap

Trident Acetabular Surgical Protocol Howmedica Osteonics Corporation 2009-07-20 2009-06-15 49269 Type II N/A N/A

do not agree with this information and are erroneous. As such, the numbers engraved on the impactor cap could cause some confusion during surgery and lead to surgical delay.

The Trident Acetabular System surgical protocol (LSP55) needs to be modified to create

Removable Magnet Hires 90K Advanced Bionics, LLC 2009-07-20 2009-06-12 49409 Type II CI 1400-01, CI-1400-01, CI-1400-02H N/A

separate and distinct surgical protocols, one for the Trident PSL Shell (LSP68) and one for the Trident Hemispherical Shell (LSP69) in order to clarify and highlight the differences in reaming technique. Advanced Bionics (AB) is notifying implant surgeons about the removable magnet component of the HiRes 90K Cochlear Implant (model no. CI-1400-01 and CI-1400-02h). The magnet is designed to be surgically removable if the Cochlear Implant patient needs to undergo an MRI. AB reports that devices manufactured between May 27 and June 30 of 2005 may have a magnet laser welding defect. The magnets were made such that the metal case surrounding the magnet is not properly welded. A patient implanted with an unwelded magnet could experience a decrease in the strength of the magnet over time, leading to headpiece retention issues. AB is aware of 14 defective magnets. In 7 cases the unwelded magnet resulted in surgery and replacement of the magnet. 2 of the replacements were for devices sold in Canada. An additional 5 potential cases outside of Canada and the USA are

A) Amplilink Software V 3.1.1B) Amplilink Software V 3.1.2 Build 0502

Roche Diagnostics Ltd. 2009-07-20 2009-06-16 48878 Type II A) CAT #04807197001B) CAT #04855094001

A) All LotsB) All Lots

under investigation. Based on random sampling AB has determined the weld failure occurred at a rate of 1 in 126 devices. Devices manufactured outside the above time frame were not affected. While running the AmpliLink software, there are possibilities (under certain circumstances) that an assay is being performed with the test file parameters of another assay.

C) Amplilink Software V 3.2D) Amplilink Software V 3.2.1E) Amplilink Software V 3.2.2

C) CAT# 04862392001D) CAT #05093236001E) CAT# 05201357001

C) All LotsD) All LotsE) All Lots

Centricity PACS Workstation - Hardware GE Healthcare Integrated IT Solutions 2009-08-03 2009-05-26 47838 Type II K2033LP > 100 Numbers, Contact Manufacturer Default configuration may have been modified so that rejected images are included in the retrieved exam, resulting in those images being displayed erroneously on external DICOM device.

A) Central Venous Catheterization SetB) Central Venous Catheter

Arrow International, Inc. 2009-08-03 2009-05-11 48476 Type II A) CS-12123-E, CS-15123-EB) MC-12123, MC-15123

A) > 10 Numbers, Contact Manufacturer B) > 10 Numbers, Contact Manufacturer

The catheters have a deformity in the lumen at the catheter juncture hub which can cause difficulty in passing the spring wire guide through the hub of the catheter or removing the spring wire guide from the catheter.

Accu-Chek Softclix Lancets Roche Diagnostics GMBH 2009-08-03 2009-06-01 48484 Type III 03146693119, 03146707119, 03583031002

> 10 Numbers, Contact Manufacturer There is a potential that a single lancet may miss the protective cap in the Accu-Chek Softclix Lancet boxes and in the bags in blood glucose meter kits.

Kuschall K-Junior Manual WheelchairStromatolyser-IM

NX 8000 With V. NX2008 Or NX.x.8000

Kuschall AGSysmex Reagents America

AGFA Healthcare N.V.

2009-08-032009-08-03

2009-08-03

2009-06-152009-06-26

2009-06-22

4929349463

49490

Type IIType III

Type II

K-JuniorSIM-220A

NX SOFTWARE 2.0.7000, NX

806135534c0910, c9011, c9013, c9014, c9015, c9016, c9017N/A

A breakage of the pushbuggy handle has been occurring at a calculated weight of 65 kg.Seven lots of Stromatolyser-IM (SIM-220A) manufactured between March 3,2009 and March 26th,2009 have tested positive for a pseudomonas type species of bacteria. Under certain circumstances, after opening and closing a study on a CMS system while a

SOFTWARE 2.0.8000, NX SOFTWARE 3.0.7000, NX SOFTWARE 3.0.8000

study is still open on an in-room NX system, a problem of image mis-up can occur on the in-room NX system.

Kodiak Power Supply

Acuson P50 Diagnostic Ultrsound System

Breg, Inc.

Siemens Medical Solutions USA, Inc.

2009-08-03

2009-08-03

2009-06-18

2009-06-19

49511

49589

Type II

Type III

N/A

10041762

3508, 3908, 4308, 4808

10120, 10122

The power supply have short circuited at the electrical outlet upon initial use of the power supply, causing the circuit breaker for the specific electrical outlet to trip.1) In versions 1.1 and 1.1, the needle guide feature was to be disabled for all transducers but actually activated for 1215 transducer. 2) In non-cardiac application, can be an error in

on the calibration report. Real time testing in manufacturing indicates the stability claim of 24 months will not be met for lot numbers: M802452, M804502, M807345 and M808329. Calibration failures occur at 12 months.

Icelock expulsion valve 551

Stellant CT Dual Injector Systems P3T

OSSUR HF

Medrad Inc.

2009-08-03

2009-08-03

2009-06-25

2009-06-19

49594

49618

Type II

Type II

N/A

3007301, 3010432, 3014849

CO081010

N/A

The plastic cap on valve may detach from valve body breaking the vacuum and allowing the prosthesis to loosen or completely detach. 1. When P3T cardiac protocols are programmed with saline test inject and used in conjunction with ISI 700 or ISI 800 products and the Stellant CT Injection system, the pre-diagnostic protocol must include a transit bolus.

A) Cancellous Bone ScrewsB) Gap Plate Screw

Howmedica Osteonics Corporation 2009-08-03 2009-07-03 49712 Type II A) N/AB) N/A

A) > 10 Numbers, Contact ManufacturerB) > 10 Numbers, Contact Manufacturer

2. A defect in SW version 103.0 and 104.0 of the Stellant CT injection systems may cause ISI 700 accessory to incorrectly trigger bolus tracking on a Philips CT system for P3T cardiac protocol.

Stryker has become aware that the third party supplier, for material used to manufacture the Cancellous Bone Screws and Gap Plate Screw, did not comply with metallurgical requirements outlined in the ASTM standards for titanium surgical implants. As such, areas of modified material properties may result, which may affect the intended use of the product. Although testing demonstrated the affected lots to have shear strength equivalent to screws

A) Restoration Modular Calcar BodiesB) Restoration Modular Hip Body/Bolt STDC) Restoration Hip Body/BoltD) Restoration Mod. Hip Broach Body/BoltE) Restoration Modular Conical Distal StemF) Restoration Modular Conical Bowed Stem

Howmedica Osteonics - Stryker Ireland 2009-08-03 2009-07-03 49713 Type II A) N/AB) N/AC) N/AD) N/AE) N/AF) N/A

A) T80998AA, T80998AC, T80550AA, T81105BA, T55344DA, T80551AA, T80554AAB) > 10 Numbers, Contact ManufacturerC) 29054602, 29110402, 28749101, 28932002, 28719201, 28914301, 29054902, 28932601D) 29389202

manufactured from non-affected material, the potential for variability of the material used in manufacturing the affected lots could compromise the strength.

The third party supplier, for material used to manufacture the Restoration Modular Components, has demonstrated poor process control which has raised concerns about the quality of the raw material supplied. As a precaution and due to the potential impact on the mechanical properties of the affected products, Stryker is recalling all products manufactured from material supplied by this supplier.

Paradigm Quick-Set Infusion Sets Unomedical A/S 2009-08-03 2009-07-07 49737 Type I MMT-396, MMT-397, MMT-398, MMT-399

E) CAXJ826A, CAXJ827A, CAXJ910A, CAXJ834A, CAXJ834C, CAXJ834J, CAXJA29DF) CAXJ951A> 10 Numbers, Contact Manufacturer Approximately 2% of infusion sets in the affected lots (lots starting with 8) may not allow the

insulin pump to vent properly. Venting is necessary to equalize the pressure in the reservoir compartment with the surrounding atmosphere. If the vent does not work properly, this could result in too much or too little insulin being delivered. / Environ 2 % des dispositifs de perfusion des lots concernés (lots commençant par 8) ne permettent probablement pas à la pompe à insuline de s’aérer convenablement. L’aération est nécessaire pour pressuriser le compartiment de la seringue, où est inséré le réservoir, par rapport à l’air ambiant. Si la bouche d’aération fait défaut, il peut en résulter une administration excessive ou insuffisante

'903' Newborn Screening Cards Whatman, Part Of GE Healthcare 2009-08-03 2009-05-27 49796 Type III N/A Lot # 6828908, 6829008, 6818808d’insuline.Partial or complete detachment of the '903' paper from the demographic portion of the '903' newborn screening card may occur, which may necessitate a re-screening.

PCR AC-500/PCR AC-5000 Basic System Philips Medical Systems DMC GMBH 2009-08-03 2009-02-23 46769 Type II MCR1511 N/A Possibility that choice of patient will be changed when using filtered work lists. Normally problem detected because the "active" name of patient is displayed. This affects PCR Eleva

Apexpro Telemetry System - Transmitter GE Healthcare 2009-08-03 2009-02-20 45337 Type II APROCH-XX-XXX-XXX-X S/N RT908139180GAsystem connected to a RIS. Potential for intermittent or unpredictable circuit board failures due to insufficient copper plating resulting in loss of communication and patient data.

Hispeed FXi, LXi System GE Healthcare 2009-08-03 2009-01-13 45604 Type III B7520AZ, B7530AZ > 10 Numbers, Contact Manufacturer X-ray leakage from diagnostic source (tube + collimator) exceeded 21CFR regulatory requirement and IEC standard. Concerns of increased patient exposure due to leakage of radiation.

CIC Pro Clinical Information Center GE Healthcare 2009-08-03 2009-06-05 46547 Type II CIC-XXXX-XXXXX-XXXXX* > 100 Numbers, Contact Manufacturer Large number of time change requests between two or more CARESCAPE devices may result in sluggishness of CIC Pro, loss of waveforms, parameters & alarming and

A) Brilliance 40/64 Slice CT SystemB) Gemini TF PET/CT System

Philips Medical Systems (Cleveland), Inc. 2009-08-03 2009-07-16 46654 Type II A) 4550 110 02031B) 4550 110 09021

A) N/AB) N/A

inconsistent time values. There is potential for data to be lost during reconstruction of images in which slices can either be disregarded or interleaved based upon their series ID.

2.0 Compression L Plate, 6 Hole Left

A) Sabouraud Dextrose Agar

Walter Lorenz Surgical, Inc. Also Trading As: Biomet Microfixation

PML Microbiologicals, Inc.

2009-08-03

2009-08-03

2009-06-29

2009-06-30

49529

49558

Type III

Type III

62-5442

A) 303434

24180

A) 286801-1, 287425-1

The possibility of part number 62-5442 2.0 Compression l Plate, 6 Holes Left package may have contained a similar part 62-5441 2.0 Compression l Plate Right instead of the 62-5442 part. Specific lots of prepared plated media may be experiencing random fungal contamination.

B) Middlebrook 7H11 AgarC) TSA + 5% Sheep Blood (BA)D) Nitrient AgarA) BHS 301B) BHS 202C) BHS 102 D) BHS 130E) BHS 301 SCULPTORF) BHS 302G) BHS 135

Body Health S.A. 2009-08-03 2009-07-01 49781 Type II

B) P2377C) P2600D) P3889A) BHS 301B) BHS 202C) BHS 102D) BHS 130E) BHS 301 SCULPTORF) BHS 302G) BHS 135

B) 286811-1, 287223-1C) 287232-1D) 287173-1A) 131108-0471, 131108-0472, 131108-0474B) 160708-0134, 090408-0090C) 080408-0082, 080408-0094, 120508-0112, 120508-0113, 120508-0114, 120508-0115, 120508-0107, 120508-0116, 120508-0106D) 201207-0137E) 181108-0179

A notification was sent to the distributor informing them that the medical devices that were sold to them by Body Health S.A. were not licensed in accordance with the medical devices regulations.

H) BHS 140 H) BHS 140 F) 050208-0087G) 140108-0238

A) Posey Soft Belt With Crotch StrapB) Posey Breezeline Pelvic HolderSynchron Rheumatoid Factor (RF) Reagent

J. T. Posey Co.

Beckman Coulter Inc.

2009-08-03

2009-08-03

2009-07-08

2009-07-08

49840

49912

Type II

Type II

A) 4125CB) 4411475136

H) 070607-0021A) N/AB) N/AM802452, M804502, M807345, M808329

Label clarification.

As the Synchron RF Rreagent ages, it may fail calibration with the condition of "math error"

Smartmonitor 2 With PCMCIA Respironics Inc. 2009-08-17 2009-05-11 48114 Type I 4002, 4003 S/N: 3000033364 to 3000038740 There is a variation in the SmartMonitor 2 manufacturing process that could allow the wire harness attached to the alarm to be pinched between the upper and lower case of the SmartMonitor 2 units. If the wire harness is pinched such that the conductive wi

AW Volumeshare2 - CT Perfusion 4 GE Healthcare 2009-08-03 2009-06-16 48164 Type II 5189396 > 10 Numbers, Contact Manufacturer When using CT Perfusion 4 algorithm on data with longer time sampling intervals, under certain conditions, the noise level in the functional maps may prevent user from clearly seeing a subtle perfusion defect.

Fetal Bleed Screening Test

A) Pediatric Emergency System KitB) Pediatric Emergency System Flying CarpetC) Emergency System Intraosseus Module

Immucor Inc.

Vital Signs Inc.

2009-08-03

2009-08-03

2009-07-01

2009-06-30

49726

49853

Type II

Type II

7892

A) 7730ALS, 7730BLU5, 7730GRN5, 7730IALS, 7730MOD, 7730ORG5, 7730PUR5, 7730RED5, 7730WHI5, 7730YEL5B) 7730FLY

17411

A) 245F to 366F inclusive, 001K to 149K inclusiveB) 001K to 149K inclusive, 245F to 366F inclusiveC) 245F to 366F inclusive, 001K to 149K

Complaints of particulate matter in the indicator cells, positive and negative control components of the test kit. An investigation has confirmed microbial contamination in one vial of indicator cell. The Broselow/Hinkle Intraosseus Module, which is part of the Broselow/Hinkle Pediatric Emergency System, contains a 15g intraosseus needle that is not compatible with the IV extension set that is provided in the module. This may result in a leak at the connection, delaying treatment.

C) 7700BIO2, 7700GIO2, 7700OIO2, 7700PIO2, 7700RIO2, 7700WIO2, 7700YIO2

inclusive

Fogarty Occlusion Catheter Baxter Healthcare Corporation, 2009-08-03 2009-06-29 49905 Type II 62080822F > 100 Numbers, Contact Manufacturer Two parts of the tubular packaging could become loose under the shrink wrap that holds the

Damon SS Archwire 227-1043Synchromed II Implantable Infusion Pump

Edwards Critical-Care Division

Ormco CorporationMedtronic Inc.

2009-08-032009-08-03

2009-05-012009-07-14

4995649972

Type IIIType II

227-10438637

20994915> 100 Numbers, Contact Manufacturer

directions for use insert on the packaging tube and could render the product non-sterile.

Damon SS Archwire 227-1029, 26 mm, mislabeled as 227-1043, 40 mm. Reduced battery performance (estimated at 2.1% of affected population) has resulted in 8 occurrences of low battery reset between 47 and 56 months, and 1 occurrence of premature elective replacement indicator (ERI) at 54 months post-implant. For affected pumps, the minimum time frame of 90 days between ERI and end of service (EOS) may also be reduced.

Tina-quant a Apolipoprotein A1

Trinical Reference Plasma T5102

Roche Diagnostics GMBH

Trinity Biotech PLC

2009-08-03

2009-08-03

2009-07-17

2009-05-21

49761

49894

Type III

Type II

3032612122

T5102

All Lot Numbers

R332037, R332037R, S287001

The manufacturer identified a reduction of the on board stability from 42 days to 14 days for the Hitachi Tina-quant Apolipoprotein A1 reagent when used on the Roche Hitachi 912 and 917 and MODULAR P systems.Trinity Biotech initiates a corrective field action for TriniCAL Reference Plasma, product code T5102 (lots R332037, R332037R and S287001). The protein C chromogenic value is misassigned in these lots and can result in an erroneous protein C chromogenic activity result.

Triniclot APPT S, Cat. No. T1202 Trinity Biotech PLC 2009-08-03 2009-04-23 49895 Type II T1202 S067009 Precision and open vial stability issues with this lot may result in increased or decreased aPTT times across the range of the assay. The lot is not stable for the full 30 day period

Trinclot APTT HS, Product Code T1204 Trinity Biotech PLC 2009-08-03 2009-05-25 49896 Type II T1204 R324001when opened and stored at 2-8 c as recommended.Precision issues with this lot may result in increased aPTT times across the range of the

Varelisa MPO ANCA Phadia GMBH 2009-08-03 2009-04-09 49897 Type III 17696 32assay. The negative control shows an elevated signal. It can exceed the upper quality control limit of 0.200 OD given in the directions for use.

A) Bypass TGH KitB) Valve TGH Kit

Cardinal Health 2009-08-03 2009-07-13 49952 Type II A) PC30CG'XXX'B) PC30VP'XXX'

A) 870139, 878608, 866059, 874187, 876386, 882391, 888414B) 878586, 866060, 874182, 874678, 884383

The unit package seals on the BD 60 ml Luer lock syringes, a component of the Cardinal Health custom sterile packs may have been adversely affected as a result of an issue during the packaging process.

Clinac IX Radio Therapy Delivery System

Triage Tox Drug Screen PN 94400

Varian Medical Systems, Inc.

Biosite Incorporated

2009-08-03

2009-08-03

2009-05-29

2009-05-29

50003

50030

Type II

Type III

2100C, 21EXS, CLINAC IX H14, CLINAC IX H27, CLINAC IX H29

94400

> 10 Numbers, Contact Manufacturer

> 10 Numbers, Contact Manufacturer

On Clinacs running C- series version 7.X, the couch can be moved via the float mode when the stereotactic motion disable function is turned on. This may represent a hazard to a stereotactic patient with a head ring mounted on a floor stand or pedestal.Biosite, Inc. initiates notice of correction for Triage TOX Drug Screen Kit, PN 94400. Boxes

A) Aeroset System - Total Bilirubin Assay Abbott Laboratories Diagnostic Division 2009-08-03 2009-07-10 49921 Type III A) 6L45-20, 6L45-40 A) All Lots

shipped after August 6, 2008 are misprinted on the right side of the box flap. The misprint incorrectly states "use EDTA whole blood or plasma sample only". The kit is intended for use with urine samples not blood or plasma. Abbott Clinical Chemistry Total Bilirubin (6L45) demonstrated under-recovery on one clinical

B) Architect System - Total Bilirubin Assay B) 6L45-20, 6L45-40 B) All Lots neonatal specimen resulting in a value less than the linear limit. A linear high flag (LH) was therefore not generated. The specimen was known to have a bilirubin concentration higher than the linear limit.

Brightview Gamma Camera Sy. w/ 3/8" Crystal & Detector Caudal Cephalic

Philips Medical Systems (Cleveland), Inc. 2009-08-03 2009-07-14 49947 Type II 2170-3002A N/A If the radius drive assembly on the detectors of Brightview Gamma Cameras is severely compromised, the detector may slide, under the influence of gravity, to its hardware limit.

Uniglide Femoral Component, Non-Cemented Corin Limited 2009-08-17 2009-07-20 49985 Type II 514.0300, 514.0400 KNRU, KNTK The nonconforming devices were comingled during the manufacturing process. For lot KNRU, there are devices in unit boxes with labels marked size 4 and devices marked

Reusable Metal Needle Guides & Bushings GE Healthcare 2009-08-17 2009-04-30 48986 Type I N/A > 10 Numbers, Contact Manufacturer'514.0400, size 4', that are actually size 3. For lot KNTK, there are devices in unit boxOperator manual does not contain description of a re-sterilization process for reusable biopsy metal needle guides for the stereotactic positioner.

Sonara Transcranial Doppler System Cardinal Health 209, Inc. DBA Viasys Healthcare Inc, Viasys Neurocare 2009-08-17 2009-02-11 49919 Type II 982A0470 PWH0201 Various forms of system lockup or display screen "freezes" can occur. Surgical monitoring has a remote probability that a lockup could cause any permanent impairment of the body

Instatrak 3500 System GE OEC Medical Systems Inc. 2009-08-17 2009-07-23 49926 Type II 1006236-001 S/N'S IT35079, IT35214P, IT35226Pfunction or permanent damage to a body structure.Proper validation was not performed on using the headset in an inverted (upside down)

MIS Diamond Burs Stryker Instruments 2009-08-17 2009-07-13 49950 Type II 8420-107-120, 8420-107-125, 8420-107-130, 8420-107-135

> 10 Numbers, Contact Manufacturermanner as described in the noted system's operators manual. MIS Diamond Burs have the potential to deform and fracture at speeds above 50,000 rpm.

Cyberknife Robotic Radiosurgery System Accuray, Inc. 2009-08-17 2009-06-22 50114 Type II 27600 C185 A site reported that their End-to-End targeting accuracy was out of specification. The position of one of the robotic manipulator axes differed from the position determined by the robot controller. This discrepancy caused the CyberKnife Treatment Delivery

3.0T Signa HDX MR System - Hardware GE Healthcare 2009-08-31 2009-08-04 48251 Type II M3335PF WB0029 Contrast-enhanced 3D TOF MRA peripheral run-off studies show significant vasculature shading and right/left asymmetry, which could subject the patient to additional non-invasive examinations.

Twin-Pass Dual Access Catheter Vascular Solutions, Inc. 2009-08-17 2009-07-02 49872 Type I 5200 > 10 Numbers, Contact Manufacturer 3 occurrences of catheters containing a piece of PTFE beading material in the OTW lumen have been reported. The PTFE beading material is a processing aide used during hydrophilic coating. The beading is to be removed followed by a visual inspection prior

Easylink Informatics System

A) Advia Centaur

Siemens Healthcare Diagnostics Inc.

Siemens Healthcare Diagnostics Inc.

2009-08-17

2009-08-17

2009-07-20

2009-06-10

49974

49196

Type II

Type III

100034941

A) 07566733

All Versions

A) 37820027, 38129027, 38386027, 39195027

Inaccurate results reported to the system when a sample is diluted and placed back into the system without assigning the sample a unique, different, sample ID. As a result, patient sample results may be reported with an incorrect result value resulting inManufacturer has determined that specific lots have shown decreased specificity for

B) Advia Centaur XPUpdated recall # 49196 previously posted on 2009-07-06.

B) 07566733 B) 37820027, 38129027, 38386027, 39195027 negative populations. The positive bias of approximately 0.3 index units and specimens with 0.5 to 0.8 index may be incorrectly identified as reactive for total antibodies

Factor V Leiden Kit on LightCycler 2.0 Roche Molecular Systems, Inc 2009-08-17 2009-07-24 49994 Type III 36101790001 14674120 Possible failure of the factor V Leiden control template (positive control) included in the factor V Leiden Kit for use with the LightCycler 2.0 instrument. The factor V Leiden control template may fail to meet the validity criteria set by the macro compo

Operon D850/750/752/B810 Surgical Table Berchtold Medizen-Elektronik GMBH 2009-08-17 2009-02-03 50000 Type III B 810, D 750, D 752, D 850 3272-O10001, 3270-O10002, 3261-O10036 Upgrades initiated to avoid potential problems: pinch points and binding of release mechanism on headrest adaptors, floorlock retracting to unlock position, CPU errors involving involuntary table movements.

Welch Allyn AED10 Defib, MRL Jumpstart Welch Allyn Protocol, Inc. 2009-08-17 2009-07-30 50054 Type II 970300E, 970302E, 970302F, 970308E, 970311-E

> 10 Numbers, Contact Manufacturer If a user experiences a flashing low battery status indicator and does not understand that the device can continue to be used, the user might choose not to continue operating the device,

Compax 40E Table

A) Cancellous Bone ScrewsB) Gap Plate ScrewUpdate recall # 49712 previously posted on 2009-08-03.

GE Medical Systems LLC

Howmedica Osteonics Corporation

2009-08-17

2009-08-17

2009-07-31

2009-07-03

49649

49712

Type II

Type II

2208203, 2225864, 2225881

A) 2080-0015, 2080-0020, 2080-0025, 2080-0030, 2080-0035, 2080-0040, 2080-0045, 2080-0050, 2080-0055, 2080-0060B) 2030-6516, 2030-6520, 2030-6525,

59658ES5, 63221ES6, 69850MA6, 64076ES3

A) > 10 Numbers, Contact ManufacturerB) > 10 Numbers, Contact Manufacturer

causing therapy to be delayed or Table lock safety features are not always being utilized by the users and have resulted in unintended lateral movement that may impact patient safety. Stryker has become aware that the third party supplier, for material used to manufacture the Cancellous Bone Screws and Gap Plate Screw, did not comply with metallurgical requirements outlined in the ASTM standards for titanium surgical implants. As such,

A) Vital-Signs Monitor with Rate and MapB) Vital-Signs Monitor with Rate/Map PrinterC) Vital-Signs Monitor with Rate/Map/Printer/TempD) Vital-Signs Monitor with Temp and PrinterE) Vital-Signs Monitor with NellcorF) Vital-Signs Monitor with Nellcor SP

Welch Allyn Protocol, Inc. 2009-08-17 2009-08-04 49917 Type II

2030-6530, 2030-6535, 2030-6540, 2030-6545, 2030-6550, 2030-6555, 2030-6560

A) 53000-E1, 53000-F1B) 5300P-E1, 5300P-F1C) 530T0-E1, 530T0-F1D) 530TP-E1, 530TP-F1E) 53N00-E1, 53N00-F1, 53S00-E1, 53S00-F1F) 53N0P-E1, 53N0P-F1,53S0P-E1, 53S0P-F1G) 53NT0-E1, 53NT0-F1, 53ST0-E1,

A) All Serial NumbersB) All Serial NumbersC) All Serial NumbersD) All Serial NumbersE) All Serial NumbersF) All Serial NumbersG) All Serial NumbersH) All Serial Numbers

Speakers in VSM300 Vital-Signs Monitor failed to produce sound. The failure of the speaker eliminates audio alarm tones for parameter violation, equipment alerts, or error codes, as well as repetitive beeps to indicate pulses when monitoring SP02 (oximetr

53ST0-F1H) 53NTP-E1, 53NTP-E1R, 53NTP-F1,

4.0mm Direct Measuring Gauge

A) Alaris Patient Care System-ID ModuleB) Alaris Patient Care System-Server ModuleC) Alaris Patient Care System-PCA ModuleD) Alaris Patient Care System-ENTDAL CO2

Smith & Nephew, Inc.

Cardinal Health

2009-08-17

2009-08-17

2009-07-15

2009-07-28

49969

49979

Type II

Type II

53STP-E171117083

A) 8600, 8650B) 8015C) 8120D) 8300

All Prior To 2009 Excluding 08KM20464 & Exclud

A) > 10 Numbers, Contact ManufacturerB) > 10 Numbers, Contact ManufacturerC) > 10 Numbers, Contact ManufacturerD) > 10 Numbers, Contact Manufacturer

iThe markings on the gauge are incorrect. The discrepancy may not be apparent to the user and could result in incorrect placement of the K-wire. 1) Occluded tubing may cause medication not to be delivered. 2) Misprogrammed infusion caused by ignoring the warning message. 3) Specific ESD protection circuitry may result in an over or under infusion. 4) Certain fluids solidify in the pumping mechanis

E) Alaris Patient Care System-PumpF) Alaris Patient Care System-SPO2 ModuleG) Alaris PaA) Innova 4100 IQ - Main UnitB) Innova 2000 Cardiovascular System

GE Medical Systems SCS 2009-08-17 2009-07-31 49983 Type II

E) 8000APM, 8100LVPF) 8210, 8220G) 8110A) 2335129B) S1872LC

E) > 10 Numbers, Contact ManufacturerF) > 10 Numbers, Contact ManufacturerG) > 10 Numbers, ConA) 417372BU0, 405584BU4, 432687BU2, 406451BU5, 429328BU8, 437542BU4,

A potential power supply failure inside the GE equipment cabinet could occur with no warning & prevent x-ray generation & image processing. If this occurs, the system cannot be

A) Innova 4100 IQ - Main UnitB) Innova 2000 Cardiovascular System

GE Medical Systems SCS 2009-08-17 2009-07-31 50099 Type II A) 2335129B) S1872LC

398530BU6B) 409881BU0, 397054BU8, 419496BU5, 427075BU7, 417895BU0A) 417372BU0, 405584BU4, 406451BU5, 398530BU6

restarted.

Potential video splitter failure inside GE equipment cabinet could occur with no warning & prevent x-ray image display. System cannot be recovered without service intervention.

B) 397054BU8, 349890BU4, 347469BU9, 419496BU5, 354853BU6, 417895BU0, 364939BU9

Delta Ceramic Ball Heads Howmedica Osteonics - Stryker Ireland 2009-08-17 2009-07-27 50100 Type II 18-3200 28635501, 28575801 The third party who supplies Delta Ceramic Ball Heads did not comply with its specifications. The spherical diameter feature was measuring out of specification (oversized).

M Series Remstar Heated Humidifier System Respironics Inc. 2009-08-17 2009-07-31 50202 Type II 1049109, 1049110, 1049124, 1051157, 1051158, R1049109, R1049110,

N/A Some humidifiers may fail to operate due to a potential malfunction of the internal connection between the heater plate and the circuit board which results in a blinking blue

Active Cortisol Enzyme Immunoassay Kit Diagnostic Systems Laboratories Inc., DSL 2009-08-31 2009-07-20 50075 Type IIU1049109, U1049110DSL-10-2000 > 10 Numbers, Contact Manufacturer

light on the control knob. Active Cortisol Elisa Kits will result in falsely high values for patient samples due to a shift in the calibration of the assigned standard values.

Updated recall # 47071 previously posted on 2009- 34170, 36103, 41021 system, resulting in unintentional movement, unintentional radiation, extended 06-22. radiation or useless image, endangering the patient or operator.Cook Sydney IVF Culture Oil William A. Cook Australia, PTY. Ltd. 2009-09-14 2009-03-31 47702 Type II K-SICO-200 A833541 Higher than usual viscosity of culture oil may lead to difficulty in culturing. Communication

issued to affected facilities but no product return requested.

A) Stryker Pain Pump 120cc CathetersB) Infusion Sets For Stryker Pain PumpsC) Stryker Pain Pump 270cc CathetersD) Exfen CathetersE) Stryker Pain Pump II Infusion Sets

Stryker Instruments 2009-08-31 2009-06-23 49458 Type II A) 0500-100-000, 0500-110-000, 0500-120-000, 0500-120-025, 0500-140-000B) 0500-200-000, 0500-250-000C) 0501-100-000, 0501-120-000, 0501-140-050, 0501-416-050

A) All LotsB) All LotsC) All LotsD) All LotsE) All Lots

There is the potential for the catheter to break. Additionally there is the potential for the pain-pump to under-infuse pain medication.

F) Stryker Pain Pump2 Kits D) 0500-050-000, 0525-010-000E) 525-250-000, 525-500-000F) 0525-125-000, 540-155-000

F) All Lots

A) Dyonics Powermax Elite Motor Drive UnitB) Dyonics Mini-Motor Drive UnitC) Dyonics Power Ultralight Motor Drive

Smith & Nephew, Inc., Endoscopy Division 2009-08-31 2009-07-26 50208 Type III A) 72200616B) 7205357C) 7205971

A) N/AB) N/AC) N/A

A customer has reported that pieces of tissue remained within a Smith & Nephew shaver motor drive unit (hand piece) after the cleaning process had been completed prior to sterilization.

CyberKnife Robotic Radiosurgery System Accuray, Inc. 2009-08-31 2009-06-22 50252 Type II 28000 C202 A healthcare facility reported their end-to-end targeting accuracy was out of specification. The position of one of the robotic manipulator axes differed from the position determined by the robotic controller. Error 103 (karel e-stop detected) and error 3

Teleflex Medical Surgical Scissors Teleflex Medical 2009-08-31 2009-07-06 49787 Type II 352164, 352165, 352166, 352167, 352168, 352169, 352178

RR8, SS8, TT8, UU8, VV8, WW8, XX8, MM9, WW7, XX7, MM8, NN8, OO8, PP8, QQ8

Manufacturer has identified a defect, a rough square finish to the scissor tips rather than a smooth tip, could cause damage to the inner wall of the blood vessel rendering it unsuitable for bypass graft.

Anti-Cardiolipin IGM Test Kit Bio-Rad Laboratories Diagnostics Group 2009-08-31 2009-07-27 50175 Type II 425-2020 CL-863 Microbial contamination of Anti-Cardiolipin IGM positive control (lot CPM-591). Calibrator 3, lot CLM3-156, may also be affected. These lots are included in Anti-Cardiolipin IGM Test Kit, lot CL-863 only.

A) Tube Assembly 142, V2, V12, For DXC 600B) Tube Assembly 142, V2, V12, For DXC 800

Beckman Coulter Inc. 2009-08-31 2009-07-27 50231 Type II A) 4764, A10038B) 4764, A10038

A) All Serial NumbersB) All Serial Numbers

The wash concentrate tube assembly may fail to deliver the appropriate amount of wash concentrate on some Synchron DXC systems due to an accumulation of crystals.

C) Tube Assembly 142,V2,V12, For DXC 600iVersys Hip System Femoral Head Zimmer Inc. 2009-08-31 2009-08-06 50277 Type II

C) 4767, A10038801802802

C) All Serial Numbers60378581 This action is being conducted because the potential exists for residual buffing compound to

Staphaurex Plus 150/450 Test Kits Remel Europe Ltd. 2009-08-31 2009-03-27 50094 Type II N/A J477610, J359510be present on the surfaces of the femoral head. A potential for false positive reactions with some strains of staphylococcus epidermidis which may result in misidentification as taphylococcus aureus.

VGM 19" Monitor Welch Allyn Protocol, Inc. 2009-08-31 2009-04-21 48079 Type II VG930M S/NS > QC2082880001 48 complaints reporting that the monitors lost power unexpectedly or when they attempted to power up which resulted in loss of both visual and secondary alarm enunciation from the Updated recall # 48079 previously posted on 2009-LCD flat panel. 05-25.

Wellcolex Colour Salmonella

Oxidase Touch Sticks

Remel Europe Ltd.

Oxoid Limited

2009-08-31

2009-08-31

2009-04-03

2009-04-20

50093

50095

Type II

Type II

RE30858301, RE30858302

N/A

J438110, J438910

657819, 660081, 669024, 680190, 682455

Potential of false positive reactions (blue agglutination) for salmonella E or G serogroups with reagent # 2 included in the kits.May produce weak positive or false negative results.

A) Integrated Power Console (ENT)B) Integrated Power Console (NT)

Medtronic Xomed 2009-08-31 2009-07-27 50207 Type III A) 1898001B) EC300

A) 71358, 71360, 71357, 71361B) 51033, 51356, 51508

An error code (code 13) is displayed on some of the consoles when a stylus or EHS hand piece is connected to the integrated power console (IPC) indicating that the hand piece has not been recognized by the console. When this happens the stylus or EHS HP i

Lasertek 5000 Scalp Laser 2009-08-31 2009-07-10 50348 Type III N/A N/A The Lasertek 5000 has been classified as a class II device in Canada. This device is not

TDWorkstation Working With Sebia Hyris Technidata S.A.S. 2009-08-31 2009-07-26 50203 Type II TD-WST-01 V.11.11.A, V.12.51.A, V.12.61.Acurrently licenced for use in Canada. In a specific case, the TDWorkstation sends the total protein result to the instrument for a wrong patient. Software defect 24578.

A) CoaguCheck XS InstrumentB) CoaguCheck XS Plus Monitor

Roche Diagnostics GMBH 2009-08-31 2009-08-13 50168 Type II A) 3666794 B) 04800842190

A) All Serial NumbersB) All Serial Numbers

The cleaning procedure as recommended in the instrument's manual can lead to falsely elevated PT/INR results. This procedure may include liquid into the meters which can lead

Elecsys Anti-CCP reagent Kit Roche Diagnostics GMBH 2009-08-31 2009-07-31 50171 Type III 5031656190 Lots #153989 And Aboveto the creation of electrical bridging between heater pins. Reduction on the measuring range from 7-100 u/ml to 7-500 u/ml for the product Anti-CCP Reagent Kit.

A) Sheri-I-Bronch Endobronchial Tube KitB) Sher-I-SWIV Double Swivel Tracheal Tube

Teleflex Medical 2009-08-31 2009-07-31 50274 Type I A) 5-16028, 5-16035, 5-16037, 5-16039, 5-16041, 5-16128, 5-16135, 5-16137, 5-16139, 5-16141B) 5-15301, 5-15401

A) > 10 Numbers, Contact ManufacturerB) > 10 Numbers, Contact Manufacturer

It has come to the attention of Teleflex that the tether attaching to the double swivel cap may partially or completely break at the attachment points. The broken tether may lodge inside the dual swivel tubing or body during shipment to the end user resu

Heartstart MRX Defibrillator/Monitor Philips Medical Systems 2009-08-31 2009-07-02 50290 Type II M3536A > 100 Numbers, Contact Manufacturer In certain external transport use environments, the mechanical/electrical connection between the pads therapy cable (including pads/CPR cable) and the Heartstart MRX Defibrillator/Monitor may wear at an increased rate. Without routine operational checks,

Lightwave Ablator IA-2000-S Linvatec Corporation D.B.A. Conmed Linvatec 2009-08-31 2009-08-05 50376 Type II IA-2000-S > 10 Numbers, Contact Manufacturer (Numbers With Expiration Dates From July 2009 to Sept. 2013)

The manufacturer has determined there is a possibility that the device may not shut off if the ablate button is released.

Conmed Linvatec Arthro-Knife Linvatec Corporation D.B.A. Conmed Linvatec 2009-08-31 2009-08-05 50381 Type II 70-0071-103, 70-0071-113, 70-0072-003, 70-0073-003, 70-0074-103, 70-0075-003, 70-0076-003, 70-0077-103, 70-0078-103

> 10 Numbers, Contact Manufacturer (Lot #'s With Expiration Dates Of July 2009 to August 2013)

Manufacturer has determined there is the possibility that the device may not fully retract once it is deployed.

Aquillion One Toshiba Medical Systems Corporation 2009-08-31 2009-08-11 50342 Type II TSX-301A/2 > 10 Numbers, Contact Manufacturer In Aquilion One System, due to the problem of software and other, a part of the image-related information may be abnormal, or an error may occur at the time of scan setup when sure exposure 3D is used.

Clearview HCG Unipath Limited 2009-08-31 2009-06-29 50405 Type II 506788 All Lot Numbers. The manufacturer has updated the instructions for use to state "read the result at 3 minutes. Do not interpret the result after 3 minutes". Previously the instructions allowed tests to be

Sireskop SX/SD Siemens AG 2009-09-14 2009-02-11 47071 Type III 10093754, 31 11 676, 3111668 21005, 21040, 21087, 21107, 21110, 31036, read up to 10 minutes.Penetrating liquids or sprays entering the system may lead to malfunction of the

A) PKS Seal Open Forceps, Curved Jaw With CordB) Plasmakinetic Curved Jaw Open ForcepsC) Plasmakinetic Straight Jaw Open ForcepsD) Plasmakinetic Angle Jaw Open Forceps

Gyrus Acmi, Inc. 2009-09-14 2009-08-18 50595 Type II A) 915000PK, 915005PK, 915010PKB) 3103PKC) 3104PKD) 3105PK

A) All Lots Prior To 2009-08-14B) All Lots Prior To 2009-08-14 C) All Lots Prior To 2009-08-14D) All Lots Prior To 2009-08-14

The metal shim between the jaws may detach during the procedure and fall into the surgical field. It has been reported that the detached shim may be undetected and be left behind in the patient.

A) Van SonnenbergB) Flexima Hydrophilic All PurposeC) Flexima Hydrophilic DrainageD) Flexima Hydrophilic Biliary Drainage

Boston Scientific Corporation 2009-09-14 2009-03-23 47710 Type III A) 20-307, 21-306, 21-307, 27-303, 27-304, 27-315, 27-316B) 27-124, 27-131, 27-132, 27-133, 27-134, 27-135

A) > 10 Numbers, Contact ManufacturerB) > 10 Numbers, Contact ManufacturerC) > 10 Numbers, Contact ManufacturerD) > 10 Numbers, Contact Manufacturer

Boston scientific has decided to revise the DFU for all affected products to include more detailed info about sutures separating from catheter.

E) Flexima Hydrophilic Drainage KitF) Flexima Hydrophilic NephrostomyG) Flexima Hydrophilic Nephrostomy Catheter

C) 27-196, 27-197, 27-198, 27-199D) 27-154, 27-155, 27-156, 27-157, 27-158, 27-159, 27-160, 27-161, 27-162, 27-

E) > 10 Numbers, Contact ManufacturerF) > 10 Numbers, Contact ManufacturerG) > 10 Numbers, Contact Ma

H) VTC NephrostInterDry Ag Coloplast A/S 2009-09-14 2009-07-28 50228 Type II

260, 27-261, 27-262, 27-263, 27-2647910 1789435 Coloplast became aware of an InterDry AG stability test failure in that a sample submitted

for testing contained no silver. Only a portion of 1 lot did not meet product specifications for

A) VNS Demipulse SYS ProgrammingB) VNS Demipulse SYS Programming Software

Cyberonics Inc. 2009-09-14 2009-08-11 50356 Type II A) 250 (Versions 6.1 And Less)B) 250, 250 V7.1.4

A) All Versions And Lot NumbersB) All Versions And Lot Numbers

silver content. In rare instances, a system diagnostic test using model 250 programming software (v 7.1 and earlier) may report "lead impedance: ok" when, in fact, normal wear and trauma has

A) Gyroscan Intera ACS 1.5 Tesla MR System B) Intera 1.5T MR Systems - Coils

Philips Medical Systems Nederland B.V. 2009-09-14 2009-08-14 50406 Type II A) N/AB) N/A

A) 5354, 5220, 5418, 99220, 5572, 5465, 5438B) 8985, 10236, 8256, 22658, 8672, 8442, 8379,

resulted in a short-circuit condition that prevents the lead from delivering theThe combined use of the Synergy Flex-M/Shoulder Coil 1.5T with other coils increases the chance of RF interaction and heating up of the coil. This may result in possible burns of the

Aquesure Disposable Filters Bomimed Inc. 2009-09-14 2009-04-30 50420 Type II N/A8240, 10183, 10566042709, 042309, 042209

patient. This applies to all Intera 1.5T and Gyroscan Intera ACS 1.5T MRA customer could not get a CO2 tracing while the anesthesia circuit was in use because the CO2 port on the filter was blocked with the plastic mould. Lot numbers listed are the

Magna-FX Cannulated Screw Fixation Zimmer Inc. 2009-09-14 2009-08-14 50432 Type III 114607000 60471710affected anesthesia circuits. Some units in the affected lot of Magna-FX Cannulated Screw Fixation System cannulated bone screws may not have the hex broached into the head of the screw, making driver

Hydrodissector Cannulas Hurricane Medical 2009-09-14 2009-05-14 50440 Type II 4027 90402engagement impossible. It was discovered during final review of the product 4027, lot 090402 that the wrong product was issued for packaging. A similar ophthalmic cannula, product 2027 was inadvertently

Ultrapower Diamond Wheel Bur Linvatec Corporation D.B.A. Conmed Linvatec 2009-09-14 2009-08-04 50380 Type II 7021-092, 7021-292, 7021-393 > 10 Numbers, Contact Manufacturerretrieved and packed as a product 4027.This device ID was included because of the error on device ID #23037. The catalogue # 7021-392 was wrongly listed under device ID 406636 instead of 406639. Company already have send corrective fax-back to MDB.

Datex Ohmeda Carestations Interface GE Healthcare Finland OY 2009-09-14 2009-04-14 47422 Type II M1079844 > 10 Numbers, Contact Manufacturer The N-DISVENT-02 acts as an interface between the anesthesia machine or ventilator and the patient monitor. Because of incorrect patient weight and/or height synchronization between anesthesia machine/ventilator and the patient monitor through the N-DISVE

A) VNS Model 250 Programming Software Cyberonics Inc. 2009-09-14 2009-07-31 50356 Type II A) 250, 250 V7.1.4 A) All Versions And Lot Numbers In rare instances, a system diagnostic test using model 250 programming software (v 7.1 B) VNS Demipulse System Programming Software

HTA System Boston Scientific Microvasive 2009-09-14 2009-08-05 50466 Type II

B) 250 (Versions 6.1 And Less)

M006550160, M006550161,

B) All Versions And Lot Numbers

> 10 Numbers, Contact Manufacturer

and earlier) may report "lead impedance: ok" when, in fact, normal wear and trauma has resulted in a short-circuit condition that prevents the lead from delivering thePossibility of thermal injury to patient resulting from fluid leakage at the cervix around the

Hi-Art System Tomotherapy Incorporated 2009-09-14 2009-08-13 50472 Type IIM006560200, M006560201101264 10037, 10169, 10014, 10072, 10130, 101212,

110009, 110129

sheath. During radiation treatment the usual data were not visible on the operator station display, even though the rad on indicators were active. The treatment was then stopped at around

Clay Adams Dynac III Centrifuge Becton Dickinson And Company 2009-09-14 2009-08-17 50475 Type III 420104 8192744, 8288054the 4min mark, but the system did not mark the treatment as interrupted. WhLatch bar on centrifuges may have been improperly assembled. May become loose, disabling safety feature which prevents customers from opening centrifuge while it is

A) Anesthesia ManagerB) PACU Manager

Picis Inc. 2009-09-14 2009-08-10 50507 Type II A) Model/Catalog #: 4220B) Model/Catalog #: 4245

A) S/W version 7.1B) S/W version 7.1

spinning. A problem may occur when an order of long duration (those continuing for several days) is discontinued. Due to the configuration of the buffer storage in local memory it may not set

C) Critical Care ManagerPedicap / Pedicap 6 Covidien LP - Respiratory & Monitoring Solutions GBU 2009-09-14 2009-08-18 50527 Type I

C) Model/Catalog #: 1110Pedicap, Pedicap 6

C) S/W version 7.1> 10 Numbers, Contact Manufacturer

the status of the future tasks to "done". In this rare instance it will cA recent modification to Pedicap end-tidal co2 detector may result in increased resistance to

Warmer, Infant Radiant Draeger Medical Systems, Inc. 2009-09-14 2009-07-20 50549 Type I 1250, 1500, 200, 2000, 2000/3000, All Serial Numbers

airflow through Pedicap and may cause ineffective ventilation of patient and inadequate detection of co2 levels, so that the indicator paper will not change coloAfter a brief intense fire in a neonatal unit in the United States, an ECRI investigations

G40, X150, X300 Ultrasound System Siemens Medical Solutions USA, Inc. 2009-09-14 2009-08-12 50581 Type III2200/3200, 300, 3000, 3200, 79 FMT8648375 302351, 303316, 300477

concluded the stabilet was the ignition source for the fire. Letter to inform all customers on how volume flow calculations are calculated on the affected ultrasound systems and that the formulas determining flow volume are described in the included manual addendum.

H) Replus Implants H) N/ACobra Electrosurgical System Boston Scientific EP Technologies 2009-09-14 2009-08-05 50601 Type II M00448100, M00448110, M0048400 > 10 Numbers, Contact Manufacturer Potential to deliver RF energy without depressing the foot switch. If foot switch is not

depressed, and the audible sound is heard and/or the indicator light is on, the foot switch is not functioning properly.

A) Expo Angiographic Catheters, amplatzB) Impulse Angiographic Catheter, amplatzC) Impulse Angiographic Catheter, brachialD) Impulse Angiographic Catheters,femoralE) Impulse Angiographic Catheters,internalF) Impulse Angiographic Catheters,leftG) Imp

Boston Scientific Corporation 2009-09-14 2009-08-07 50383 Type II A) 08526-01B) 16391-100C) 16391-11D) 16391-02E) 16391-201F) 16391-190G) 16391-117 H) 16391-174I) 16391-40J) 16391-180K) 16391-203L) 08526-150M) 08526-21N) 08526-01O) 08526-201P) 08526-190Q) 08526-146R) 08526-40S) H749085263002T) 08526-1

A) N/AB) N/AC) N/AD) N/AE) N/AF) N/AG) N/AH) N/AI) N/AJ) N/A K) N/AL) N/AM) N/AN) N/AO) N/AP) N/AQ) N/AR) N/AS) N/AT) N/AU) N/A

Sterile barrier in the packaging may be compromised.

A) Wiseguide Guide Catheters, bypassB) Wiseguide Guide Catheters, multipurposeC) Wiseguide Guide Catheters, q-curve

Boston Scientific Corporation 2009-09-14 2009-08-07 50383 Type II A) 16320-122B) 16320-131C) 16320-293

V) N/AW) N/AX) N/AY) N/AA) N/AB) N/AC) N/A

Sterile barrier in the packaging may be compromised.

D) Wiseguide Guide Catheters, radialE) Wiseguide Guide Catheters, contralateralF) Wiseguide Guide Catheters, cls

D) 19500-474E) 16320-573F) 16320-573

D) N/AE) N/AF) N/A

G) Wiseguide Guide CatMC5057 Universal Cable Linvatec Corporation D.B.A. Conmed Linvatec 2009-09-14 2009-08-14 50401 Type II

G) 16320-583MC5057

G) N/AN/A The possibility that a sufficiently worn/damaged Universal Cable MC5057, when used with

Emax 2 Plus System - Foot Pedal The Anspach Effort Inc. 2009-09-14 2009-08-17 50456 Type II EPLUS-FP SN C08301701901

various Conmed Linvatec electric handpieces may cause the handpiece to self activate.

The foot control cable lacks the shield connection from the cable to the connector body.

A) Brainscan Radiotherapy System-SoftwareB) iPlan RT Dose-Planning Software

A) Oximetrix 3 System SO2/CO ComputerB) Lifecare PCA 4100 Plus InfuserC) Lifecare 5000 Plum Infusion Pump System D) Plum XLE) Omni Flow 4000 Plus IV Medication MSF) Plum XL Micro/Macro With Data Port XLDG) Plum XL Micro/Macro Infusion (XLM)H) Plu

Brainlab AG

Hospira Inc.

2009-09-14

2009-09-14

2009-08-12

2009-08-20

50497

50517

Type I

Type II

A) 20630B) 20630

A) 50130B) 1950C) 2507D) 11555E) 40051F) 11859G) 11846H) 11781I) 186706

A) N/AB) N/A

A) N/AB) N/AC) N/AD) N/AE) N/AF) N/AG) N/AH) N/AI) N/A

The lack of shielding may result in radiated emissions exceeding CISPR11. Failure to apply and verify an adequate jaw-shaped field size and field position at the linac for the used conical collimator(s) or the failure to mount and verify the correct, intended conical collimator may lead to serious injury or death of the patientPower cords may crack and fail leading to potential risks of electrical shock. Delay in setup and therapy interruption and fires which may also occur in an oxygen-rich environment.

J) 13075K) 12384, 20709

J) N/AK) N/A

Galileo 500ul Syringes

A) Screwplant ImplantsB) Screwplant Healing CollarsC) Legacy Healing CollarsD) Screwindirect Implants

Immucor Inc.

Implant Direct LLC

2009-09-14

2009-09-14

2009-08-11

2009-08-18

50526

50598

Type II

Type II

L) 11971, 12391, 20679, 20792M) 12618, 20678 64999, 65050 (Syringe)

A) N/AB) N/AC) N/AD) N/A

L) N/AM) N/AN/A

A) > 100 Numbers, Contact ManufacturerB) > 10 Numbers, Contact ManufacturerC) > 10 Numbers, Contact ManufacturerD) > 10 Numbers, Contact Manufacturer

The glue joint between the glass and the metal can be insufficient on some syringes, which can lead to leaking and possibly to breakage of the glass barrel. Cover caps exhibited visible cracks post sterilization.

E) Screwplus ImplantsF) Screwdirect ImplantsG) Replant Implants

E) N/AF) N/AG) N/A

E) > 10 Numbers, Contact ManufacturerF) > 10 Numbers, Contact ManufacturerG) > 10 Numbers, Contact M

Galileo 1000 Microliter Syringe Immucor Inc. 2009-09-28 2009-08-24 50713 Type III 65051 >10 Numbers, Contact Manufacturer The glue joint between the glass and the metal can be insufficient on some syringes, which, over the time, can lead to leaking and possibly to breakage of the glass barrel.

Galileo Echo Blood Bank Analyzer Immucor Inc. 2009-09-28 2009-08-28 50717 Type II 87000 N/A QC may not be reset after reported QC failure. This occurs because QC passed but was repeated and failed prior to the 24-hour expiration period established for the first QC.

A) Portex Tracheal Tube, Oral/Nasal, IvoryB) Portex Tracheal Tube, SiliconisedC) Portex Tracheal Tube,Murphy,SiliconisedD) Portex Polar Preformed Tracheal TubeE) Portex Tracheal Tube, Oral/NasalF) Portex Tracheal Tube, Oral/Nasal, Murphy Eye,

Smiths Medical International Ltd. 2009-09-14 2009-09-14 50611 Type I A) 100-105-025, 100-105-030, 100-105-035B) 100-111-020, 100-111-025, 100-111-030, 100-111-035, 100/126/025, 100/126/030, 100/126/035C) 100-141-025, 100-141-030, 100-141-

A) All lots prior to Sept 2009B) All lots prior to Sept 2009C) All lots prior to Sept 2009D) All lots prior to Sept 2009E) All lots prior to Sept 2009F) All lots prior to Sept 2009

Smiths Medical International Ltd. has become aware that certain Portex uncuffed paediatric tracheal tubes were manufactured with an internal diameter slightly smaller than specifications. There is a remote potential for a suction catheter to become lodged

Clear 035D) 100/134/030, 100/134/035

Capture-R Ready Screen (4) Immucor Inc. 2009-09-14 2009-08-18 50618 Type II

E) 100/112/030, 100/112/035F) 100/127/025, 100/127/0066802, 0066812 K226 Unexpected positive reactivity with this lot of product. Invalid test result due to unexpected

negative reactions with the positive control observed with this lot.HeartStart MRx Defibrillator/Monitor Philips Medical Systems 2009-09-14 2009-08-18 50623 Type II M3535A, M3536A Serial numbers US00533518 - US00535118 The devices were shipped with an incorrect configuration file, disarming the 'flashing red x'

and audible alarms when they are powered by AC or DC power and have no battery or low

Bond-1 Primer/AdhesiveStratus OCT Tomographer Vers. 6.0 Software

Pentron Clinical Technologies, LLCCarl Zeiss Meditec Inc.

2009-09-142009-09-14

2009-08-252009-08-14

5064050625

Type IIIType II

N01IABStratus OCT

186620, 190582, 190985, 183847Software Version 6.0.0

battery capacity. This also causes a weekly self diagnostic test to run houSome of the bottles had already gelled and were unusable.A defect in Version 6.0.0 of Stratus OCT instrument and review software, in certain

A) Unicel DXI800 Thyroglobulin Antibody IIB) Access System Thyroglobulin Antibody IIC) Unicel DXI600 Thyroglobulin Antibady II

Beckman Coulter Inc. 2009-09-14 2009-08-24 50639 Type III A) A32898B) A32898C) A32898

A) >618967B) >618967C) >618967

situations reports generated will have incorrectly labelled OD (right eye) or OS (left eye).The Access Thyroglobulin Antibody II (THGAB II) assay demonstrates increased low-end imprecision and false positive rate when run in conjunction (i.e. random access mode) with the Access Accutnl assay.

Synchron CX Immuno-Protein Calibrator Beckman Coulter Inc. 2009-09-14 2009-08-24 50657 Type II 442840 M901330 And Higher The recovery of the standard has shifted. Standardizaton of the Immuno Protein Calibrator Set has been re-established to IFCC reference preparation for plasma proteins, BCD-470. This has caused a shift in quality control results and patient results for Ig

Phenobarbital And Drug Calibrator 1 Beckman Coulter Inc. 2009-09-14 2009-08-28 50663 Type II 469600, 469785 Reagent part # 469785 lots M810083 and earlier, Drug Calibrator part # 469600 lots M810440 and earlier.

There is variability in results of Phenobarbital (PHE) Reagent and Drug Calibrator 1. Results may vary from -3% to +17% with different reagent and calibrator lot combinations when measured against the established gas chromatography flame ionization detect

Spinnaker Elite Flow Directed Catheter Boston Scientific Cork Ltd. 2009-09-28 2009-08-05 50289 Type II 549015-2, 549020-2, 549030-2, 559010-2, 559020-2, 559030-2

N/A Boston is sending safety alert to customers to re-emphasize the device's approved indications and remind that this product is not intended or indicated for use with glue or glue

A) I-Stat Kaolin Act CartridgeB) I-Stat Act Celite Cartridge

Abbott Point Of Care Inc. 2009-09-28 2009-08-11 50427 Type II A) 07G81-01, 07G81-02B) 07G01-01, 07G01-02

A) All LotsB) All Lots

mixtures. An inconsistency was noted in the i-Stat System manuals regarding the volume of saline used to flush an indwelling line and the volume of blood to be discarded for clearing the line

MCS+Mobile Collection System, LN 9000

Sutureless Connector Intrathecal Catheters and

Haemonetics Corporation

Medtronic Inc.

2009-09-28

2009-09-28

2009-08-31

2009-08-27

50666

50614

Type II

Type I

09000-100-E, 09000-110-EWC

8578, 8709SC, 8731SC, 8596SC

>10 Numbers, Contact Manufacturer

>10 Numbers, Contact Manufacturer

when testing coagulation cartridges. The rare possibility exists for a pump encoder failure to go undetected and cause a pump to spin rapidly and possibly infuse anticoagulant to a donor. This has occurred just one time in over fifteen million procedures in the past 10 years.Medtronic has determined that Sutureless Connector (SC) Intrathecal Catheters and

Revision Kits

A) Advia Centaur System Software Class 3B) Advia Centaur XP System Software Class 2

Siemens Healthcare Diagnostics Inc. 2009-09-28 2009-08-28 50676 Type III A) 04911855, 078-A001-14B) 078-A010-07, 09066916

A) Version 4.0 SoftwareB) Version 6.0 Software

Revision Kits are not compatible with Isomed Infusion Pumps. A physical interference between the SC Catheter Connector and the Isomed Pump prevents the SC Catheter from completely connecting to the Isomed Pump even though it may appear to be connected and feel secure. Internal testing conducted by the manufacturer has determined that Advia Centaur V. 4.0 and Advia Centaur XP V. 6.0 system software is missing range flags and no reflex testing

C) Advia Centaur XP System Software Class 4D) Advia Centaur XP System Software Class 3E) Advia Centaur System Software Class 2F) Advia Centaur System Software Class 4A) PowerProMax Battery Modular HandpieceB) PowerProMax Battery 2-Trigger/Full F HPC) PowerProMax Oscilator HandpieceD) PowerProMax Reciprocator Saw HandpieceE) MPower Battery Two TriggerF) MPower Battery Sternum Saw

Linvatec Corporation D.B.A. Conmed Linvatec 2009-09-28 2009-08-14 50403 Type II

C) 078-A010-07, 09066916D) 078-A010-07, 09066916E) 04911855, 078-A001-14F) 04911855, 078-A001-14A) PRO5100MB) PRO5200MC) PRO5300MD) PRO5400ME) PRO6202F) PRO6450

C) Version 6.0 SoftwareD) Version 6.0 SoftwareE) Version 4.0 SoftwareF) Version 4.0 SoftwareA) BBB97037, BBB97730, BBB97731, BBB97734, BBB98124, BBB98125, BBB99622, BBB99925, BBC07409, BBC07410B) >10 Numbers, Contact Manufacturer C) >10 Numbers, Contact Manufacturer D) >10 Numbers, Contact Manufacturer

after restoring definition files and reflex for Hepatitis B surface antigen (HBSAG) is not updated.

The manufacturer has determined there is a remote possibility that certain handpieces may self activate.

G) MPower Battery HandpiecesH) PowerPro Battery Trigger Handpiece

G) PRO6200, PRO6300, PRO6400H) PRO5200, PRO5100, PRO5300, PRO5400

E) >10 Numbers, Contact Manufacturer F) BBC98784, BBC98787, BBD08568G) >100 Numbers, Contact Manufacturer H) >10 Numbers, Contact Manufacturer

Uniglide Tibia, Cementless Size 7 Corin Limited 2009-09-28 2009-08-06 50619 Type III 525.07 NACN Insufficient process control of the sterile barrier (blister lid) sealing process. The devices have been sealed in blister packs. Pack test results from one day's production met minimum

TestOxidase Reagent

Staph Xtra Latex Kit

Pro-Lab Diagnostics

Pro-Lab Diagnostics

2009-09-28

2009-09-28

2009-06-30

2009-06-30

49922

49925

Type III

Type II

PL.390

PL.1080, PL.1081

5824, 5884, 5971, 6038, 6136

PL1080 Lot 6066, PL1080 LOT 6087, PL1080

requirements of the testing regime but there was a step change in the test results indicating a change to the validated process. The affected lot numbers of the reagent, normally clear or tan in colour, have shown a purple discolouration. Product performance is not affected.The affected lot numbers of the reagent, may display graininess that could be mis-

LOT 6240, PL1081 LOT 5927, PL1081 LOT 6067, PL1081 LOT 6088, PL1081 LOT 6127,

interpreted as a false positive result.

PL1081 LOT 6237, PL1081 LOT C6340, PL1081 LOT C6375

A) Renegade Fiber Braided MicrocatheterB) Renegade Hi-Flow Microtainer

Boston Scientific Cork Ltd. 2009-10-12 2009-08-26 50811 Type II A) 18-251, 18-252, 18-253B) 18-285, 18-286, 18-288, 18-289, 18-290, 18-291, 18-298, 18-299, 18-300, 18-302, 18-303

A) >100 Numbers, Contact ManufacturerB) >100 Numbers, Contact Manufacturer

Sterile barrier in the packaging of affected product may be compromised. Pouch seal (top seal) may be breached.

Search-Cyte Duo Reagent Red Blood Cells

Immulite 2000 System-Androstenedione AS

Biotest Medical Diagnostics GMBH

Siemens Healthcare Diagnostics Products Limited

2009-09-28

2009-09-28

2009-08-24

2009-09-04

50727

50731

Type III

Type III

70226

L2KAO2

169053

217

Cell II of this product tests positive with the direct coombs test which interferes with antibody screening procedures causing false positive results. Lot numbers exhibit a positive bias with quality controls and patient results (average about +20%).

Sequencer Impac Medical Systems Inc. 2009-09-28 2009-08-27 50644 Type III 10-0020 Sequencer for MOSAIQ 1.30, Sequencer for MOSAIQ 1.40, Sequencer for MOSAIQ 1.41, Sequencer for MOSAIQ 1.50, Sequencer for

The problem is a defect in the RTP Import functionality (SEQUENCER) during the import of an RTP plan, which converts the Field between coordinate systems that swap the X and Y axes (e.g., from IEC1217 to IEC601). The subject defect did not impair the accuracy of or

A) PCR Eleva SB) PCR Compano Eleva

TDX SR Power Wheelchair

Philips Medical Systems DMC GMBH

Invacare Corporation

2009-09-28

2009-09-28

2009-02-23

2009-09-02

46769

50704

Type II

Type II

A) PCR ELEVA SB) PCR ELEVA PLUS

TDXSR, TDXSR-CG, TDXSR-CG-HD,

MOSAIQ 1.60, Sequencer for MOSAIQ 2.00A) N/AB) N/A

N/A

the ability to use QA mode. Possibility that choice of patient will be changed when using filtered work lists. Normally problem detected because the "active" name of patient is displayed. This affects PCR Eleva system connected to a RIS. On some chairs the stability lock feature may not be engaging properly or consistently. If the

TDXSR-HD, TDXSR-MCG, TDXSR-MCG-HD, TDXSRV-HD

stability lock feature does not engage properly, the wheelchair may exhibit a tendency to do one or more of the following: 1) veer to one side, 2) rock forward onto its front riggings, 3) drive in an unintended circular motion, and/or 4)fall forward or to one side and injure the user.

A) Aria SoftwareB) Aria Offline Review SoftwareUpdated recall # 49074 previously posted on 2009-06-22.C0R36 15x100mm Kii Optical Access Sys

Varian Medical Systems, Inc.

Applied Medical Resources Corporation

2009-09-28

2009-09-28

2009-05-09

2009-06-09

49074

50115

Type II

Type II

A) 8.1.15, 8.5.11, 8.6.07, HITB) 8.1.15, 8.5.11, 8.6.07, HIT

C0R36

A) >10 Numbers, Contact Manufacturer B) >10 Numbers, Contact Manufacturer

1084426, 1085506, 1082348

An anomaly exists in the software, which leads to a record save fail in the case that a partially treated fraction has zero dose accumulation. If the change to the plan had been to parameters other than dose per fraction, treatment to incorrect volume could result, potentially leading to serious injury. A cannula tip had fractured during a gastric bypass procedure. The resulting fragments were recovered and the event did not directly result in patient injury. However, the surgeon converted the laparoscopic procedure to "open" to confirm all fragments were recovered. The identity of other medical devices or accessories used in the event is unknown.

A) Unipolar Intramuscular LeadsB) Enterra Gastric Stimulation Leads C) Enterra Therapy GastricC Stimulation IPG

Medtronic Inc. 2009-09-28 2009-09-04 50734 Type II A) 4300-35, 4300-50B) 4351C) 3116, 7425G

A) >10 Numbers, Contact Manufacturer B) >10 Numbers, Contact ManufacturerC) >10 Numbers, Contact Manufacturer

The recall is initiated to provide important new safety information and patient management recommendations related to the potential for bowel obstruction and/or perforation in a small percentage of Medtronic Enterra Therapy System patients. Enterra Therapy leads may wrap around or perforate the bowel.

A) Virtuoso Dual Chamber ICDB) Concerto CRT-DC) Virtuoso Single Chamber ICD

Medtronic Inc. 2009-09-28 2009-09-09 50790 Type II A) D164AWGB) C174AWKC) D164VWC

A) >10 Numbers, Contact Manufacturer B) >10 Numbers, Contact Manufacturer C) >10 Numbers, Contact Manufacturer

Affected devices may not meet expected device longevity due to gradually increasing current drain caused by low voltage capacitor degradation. This issue may present in the affected devices as reaching the recommended replacement time (RRT) earlier than

R Series Defibrillator/Pacemaker/Monitor Zoll Medical Corporation 2009-09-28 2009-09-02 50795 Type II Zoll R Series S/N AF07F001253, S/N AF08G005269, S/N AF08J005776, S/N AF08L006574, S/N

expected. R series may display an ECG fault 7 message and fail to display the ECG baseline. Failure to display the patient's ECG could delay delivery of defibrillation or pacing therapy.

TempBond Clear with Triclosan Kerr Corporation 2009-09-28 2009-09-09 50813 Type III 33351AF09B006789, S/N AF09B0067913257280, 3229807, 3268505, 3277455, 3258772, 3269811

Manufacturer received 21 complaints that catalyst portion of TempBond Clear with Triclosan syringes was polymerized and therefore unusable. An investigation confirmed the

Immulite System-Total T4 Assay Siemens Healthcare Diagnostics Products Ltd. 2009-09-28 2009-09-14 50818 Type III LKT41, LKT45 351complaints.Siemens Healthcare Diagnostics received customer complaints regarding Immulite /

Quantiferon-TB Gold In-Tube Cellestis Ltd. 2009-10-12 2009-09-01 50725 Type III N/A A090504Z

Immulite 1000 total T4 kit assay where the barcode did not correspond to the kit barcode lot number.It was observed that there were a higher than expected number of false positive results with

Ilumavision Software Ver. 2.1.0 Imtec Imaging, LLC 2009-10-12 2009-08-03 50774 Type II N/A Version 2.1.0lot A090504Z and the presence of higher levels of endotoxins was found. 1. Incorrect imaging resulting from 3rd party digital image (Dicom) incompatibility. 2. Potential incorrect patient identification on report. Both may result in inaccurate or

Heater Wire Adaptors Fisher And Paykel Healthcare Ltd. 2009-10-12 2009-07-23 50850 Type II 900MR800 All Lot Numbers inappropriate treatment. Manufacturer is replacing these adaptors with new, more advanced product, which include surge protection hardware that will reduce the risk of breathing circuit heater wire

A) AW VolumeshareB) AW Volumeshare2

GE Medical Systems SCS 2009-10-12 2009-09-15 49927 Type II A) S30321ZKB) 5183859-3, 5183859-4, 5183859-5

A) >10 Numbers, Contact Manufacturer B) S/N'S A8177079, A9062007, 9093001,

malfunction. Measurement values provided by Seno Advantage Workstations 1x. 2.0 & 2.1 may be incorrect when applied to magnification images acquired on non-GE digital mammography

Streamlab Analytical Workcell Siemens Healthcare Diagnostics Products GMBH 2009-10-12 2009-09-09 50779 Type III WorkcellA7274009, M8281004, 8354008N/A

systems, which could lead to overestimate of size of breast lesion. Customer complaints regarding Dimension Vista Systems connected to a Streamlab

Uric Acid Assay

A) Calcar Planer Surgical Protocols

Randox Laboratories Ltd.

Howmedica Osteonics Corporation

2009-10-12

2009-10-12

2009-09-15

2009-09-14

50863

50823

Type III

Type II

UA233

A) LSP42, LSP46, LSP47M, LSP48

154107

A) N/A

Analytical Workcell where it has been observed on rare occasions an intermittent low result.

UA233, batch 154107, was incorrectly labelled with an expiry date of August 28, 2011. The correct expiry date is November 29, 2010. Stryker has identified a need to provide specific instructions for initiating power to the Calcar

B) Accolade Surgical Protocol

Acuson S2000 Siemens Medical Solutions USA, Inc. 2009-10-12 2009-09-08 50793 Type II

B) LASST

10041461

B) N/A

200252, 200288, 200334, 200926, 200979, 200995

Planer prior to engagement with bone in the cutting edge, Omnifit HFX, Secur-Fit Max/Secur-Fit Plus Max, and Omnifit Eon Surgical Protocols, as well as to provide specific instructions for rasping dense bone and/or narrow intra medullary canals for the Accolade Surgical Protocol. There is an intermittent series of events in which a print or store event failure may cause the following to occur: A) The last image of a patient study can be stored with the next new patient study performed. B) If the first patient's last image had measurement results they will appear on the next patient's image. C) When a distance ratio or area ratio measurement is performed with L Testis Mass 2 measurement label, it appears in the report as R Testis Mass 2 in English only. D) When more than 4 measurements of the same label are performed they will not appear on-screen or on the printed report.

large.MC5057 Universal CableUpdated recall # 50401 previously posted on 2009-09-14.

Linvatec Corporation D.B.A. Conmed Linvatec 2009-10-26 2009-08-14 50401 Type II 537702 N/A Update: The manufacturer now requests return of the affected devices. A sufficiently worn/damaged Universal Cable MC5057, used with Conmed Linvatec Electric Handpieces may cause the handpiece to self activate.

Renegade Fiber Braided Microcatheter

Histopaque 1077-1

Boston Scientific Cork Ltd.

Sigma Diagnostics

2009-10-12

2009-10-12

2009-08-26

2009-09-21

50941

50914

Type II

Type III

18-257, 18-259

1077-1

>100 Numbers, Contact Manufacturer

038K6170

Sterile barrier in the packaging of affected product may be compromised. Pouch seal (top seal) may be breached. Bacterial contamination (Pseudomonas mendocina) in the affected device.The device is a

A) Transport Stretcher Stryker Medical 2009-10-12 2009-08-31 50938 Type II A) 0737-000-000, 0738-000-000 A) >10 Numbers, Contact Manufacturer

cell separation media and in the reported instance was used to isolate stem cells from bone marrow specimens. The isolated cells were placed into cell culture for further testing and contamination was evident after 14 days of culture. The laboratory confirmed the source of contamination was the device.The stretchers have the potential for the bushing in the braking system to fracture, which

B) M-Series StretcherC) Trauma StretcherD) Eye Surgery Stretcher

B) 1007-000-000 (SM104)C) 1027-000-000D) 1079-000-000

B) >100 Numbers, Contact ManufacturerC) >10 Numbers, Contact Manufacturer D) 0811100540, 0812101547, 0812102798, 0901034284, 0901034285

could result in the brake/steer pedal seizing. If the pedal seizes, the braking system may become inoperable and/or steering around corners may become more difficult.

Express SD Premounted Stent System Boston Scientific Corporation 2009-10-12 2009-04-14 48011 Type III H74937911515900, H74937911614900, H74937911715900, H74937912519900,

12045170, 12070363, 12073173, 12054585, 12054587, 12054580, 12082319, 12082341,

Packaging for the applicable devices may not include a written copy of the product directions for use.

H74937912618150, H74937912618900 12045167, 12085875, 12089749, 12089752, 12129028

Steris Harmony LL500/700 Surgical Light

GT Obturators

Steris Corporation

Dentsply Tulsa Dental Specialties Trading As Dentsply Endodontics

2009-10-12

2009-10-12

2009-09-14

2009-09-25

50864

50931

Type III

Type III

YG18568

GTOB20042

>10 Numbers, Contact Manufacturer

12709123

A welded seam at the joint of the spring-loaded arm of the surgical light may brake and the light head may become disengaged and fall. The product, GT Obturators, GTOB20042, lot 012709123 was found to contain mixed

Hypergel 5 Gram

Speedlink 5.5 Transverse Connector

Molnlycke Health Care AB

Zimmer Spine Austin, Inc.

2009-10-12

2009-10-12

2009-09-22

2009-09-22

50961

50964

Type III

Type III

360500

1302-55M

08D22-156-32913, 08D22-157

55QJ

instruments, size 20, taper .04 (20/.04) and size 20, taper .08 (20/.08) obturators. Hypergel 5 gram, product code 360500, lot numbers 08d22-156-32913 and 08d22-157, have been distributed with a lot number deficiency wherein the lot number listed on the packaging does not match the lot number on the individual piece. This action is being conducted because a small quantity of titanium alloy was discovered to have a discrepancy from the alloying process at another manufacturer. Alloy segregation can affect material strength. It has been suggested that the metal used to manufacture parts from lot 55QJ may have a similar problem, though testing has not shown this.

A) Definium 8000 Digital Radiographic SystemB) Proteus XR/A General Purpose RadiographicC) Revolution XR/D Digital Radiographic System

GE Healthcare 2009-10-12 2009-09-21 47780 Type II A) 2259988-2, 5131070B) 2259973-3, 2259976, 2259988, S3918KD/KEC) 2351505, 5131070, S3918LD

A) >10 Numbers, Contact Manufacturer B) >100 Numbers, Contact ManufacturerC) >10 Numbers, Contact Manufacturer

Table locks may not actuate, causing tabletop to unexpectedly float in either the lateral axes or both the longitudinal and lateral axes, which could result in patient or operator injury.

Synex II System - Central Body

A) Immulite System-Reactive Protein (CRP) AssayB) Immulite 2500 System-HIH Sensit CRP AssayC) Immulite 1000 System-Cardiac HSCRP AssayD) Immulite System-Cardiac HSCRP AssayE) Immulite 2000 System-Cardiac HSCRP AssayF) Immulite 2500 System-HSCRP Assay

Synthes (Canada) Ltd.

Siemens Healthcare Diagnostics Products Limited

2009-10-12

2009-10-26

2009-09-23

2009-09-11

50981

50797

Type II

Type II

04.808.001, 04.808.002, 04.808.003, 04.808.004, 04.808.005, 04.808.006, 04.808.007, 04.808.008, 04.808.009, 04.808.010, 04.808.011A) LCRCMB) LCRCMC) LCRCMD) LCRCME) L2KCRP2F) LCRCM

All Lot Numbers

A) 022L, 025LB) 022L, 025LC) 022L, 025LD) 022L, 025LE) 243F) 022L, 025L

Synthes (Canada), Ltd. was notified by their supplier, Synthes (USA), of six complaints reported outside the US associated with Synex II Implant (Central Body) which fully or partially collapsed in the original implant position after a period of six to fifteen months post operatively. Siemens Healthcare Diagnostics received customer complaints regarding instabilities of high sensitivity C-reactive protein adjusters and controls giving an average positive bias of 20% compared with results from previous lots.

G) Immulite 1000 System-High Sens CRP AssayH) Immulite 3000 Systems-High Sens CRP AssayI) Immulite System-High Sensitivity CRP Assay

G) LCRCMH) L2KCRP2I) LCRCM

G) 022L, 025LH) 243I) 022L, 025L

J) Immulite 1000 System-C-Reactive ProteinRevolution Centrifugal Blood Pump Sorin Group Italia S.R.L. 2009-10-26 2009-09-23 51015 Type II

J) LCRCM50300700

J) 022L, 025L0905220164, 0906240184 Sorin Group Italia has recently identified a weakness in the plastic packaging tray used for

the Revolution Centrifugal Blood Pump that might lead the packaging tray to crack. Cracks

Da Vinci S Surgical System, Model IS2000 Intuitive Surgical Inc. 2009-10-26 2009-07-01 51026 Type III IS2000 N/Ain the packaging tray can compromise the product sterility. Intuitive Surgical Inc. observed an electronics subsystem failure that resulted in partial intermittent closure of the instrument grip (IS2000 system). A software coding error in P7

Sarns Disposable Centrifugal Pump Terumo Cardiovascular System Corporation 2009-10-26 2009-07-06 51040 Type II 164275 KN10, KP08, LA12, LC16, LE15caused the error for the MTM grip. Terumo Cardiovascular Systems has received three reports of tubing disconnecting from the pump inlet of the Sarns Disposable Centrifugal Pump during cardiopulmonary bypass.

Giraffe & Panda T-Piece Resuscitation System Ohmeda Medical, A Division Of Datex Ohmeda Inc.

2009-10-26 2009-09-22 51025 Type II M1091316, M1091335, M1091365 N/A 1. Moulding flash during manufacturing of T-piece at supplier caused out of specification aperture. 2. Severity in risk analysis control document (RAC) scored low leading to less strict supplier inspection and process control requirements.

Connection Bracket 1180.36AO Maquet GMBH & Co. KG 2009-10-26 2009-09-30 51053 Type II 1180.360AO N/A The Connection Bracket show too much mechanical play at the operating room table interface for some procedures. The cause of this play, is that the hole in the lock washer, which is responsible for locking the accessory to the operating room table interface, is too

F) Screwdirect ImplantsG) Replant ImplantsH) Replus ImplantsUpdated recall # 50598 previously posted on 2009-09-14

G) N/AH) N/A

G) > 10 Numbers, Contact ManufacturerH) > 10 Numbers, Contact Manufacturer

F) N/A F) > 10 Numbers, Contact Manufacturer

A) PowerProMax Battery Modular HandpieceB) PowerProMax Battery 2-Trigger/Full F HPC) PowerProMax Oscilator HandpieceD) PowerProMax Reciprocator Saw HandpieceE) MPower Battery Two Trigger

Linvatec Corporation D.B.A. Conmed Linvatec 2009-10-26 2009-08-14 50403 Type II A) PRO5100MB) PRO5200MC) PRO5300MD) PRO5400ME) PRO6202F) PRO6450

A) BBB97037, BBB97730, BBB97731, BBB97734, BBB98124, BBB98125, BBB99622, BBB99925, BBC07409, BBC07410B) >10 Numbers, Contact Manufacturer C) >10 Numbers, Contact Manufacturer D) >10 Numbers, Contact Manufacturer

Update: The manufacturer now requests return of the affected devices. The manufacturer has determined there is a remote possibility that certain handpieces may self activate.

F) MPower Battery Sternum SawG) MPower Battery HandpiecesH) PowerPro Battery Trigger Handpiece

G) PRO6200, PRO6300, PRO6400H) PRO5200, PRO5100, PRO5300, PRO5400

E) >10 Numbers, Contact ManufacturerF) BBC98784, BBC98787, BBD08568G) >100 Numbers, Contact Manufacturer Updated recall # 50403 previously posted on

2009-09-28Impression Coping Closed Tray Nobel Biocare AB 2009-10-26 2009-05-21 48621 Type II N/A

H) >10 Numbers, Contact Manufacturer 687218 Nobel Biocare received several complaints from customers. After investigation it was

determined that one batch of Impression Coping Closed Tray Nobelactive INT RP Q6x9mm

XTEN, HLX 3004, HLX 3005 Maquet S.A. 2009-10-26 2009-09-24 50977 Type III ARD 567801093, ARD 567801094, ARD 567910901, ARD 567910910

>10 Numbers, Contact Manufacturer was mis-packaged. Excessive strain may cause impairment of the interlocking between the arm joint and surgical light. Inappropriate handling may cause a crack on the front pivot of the Acrobat 2000 spring arm.

A) Antistreptolysin O AssayB) Antistrepolysin O Assay

Siemens Healthcare Diagnostics Products GMBH 2009-10-26 2009-09-24 50979 Type III A) K7058B) K7022

A) 07310MA, 08029MA, 08252MA, 08336MAB) 07311MA, 08043MA, 09077MA, 07177MA

Under certain conditions the software falsely elevated the results particularly if the preceding serum sample has a higher volume and concentration of beta2-microglobulin, anti-

C) IGM Flex AssayD) ASL Flex ReagentSarns Disposable Centrifugal Pump Termo Cardiovascular System Corporation 2009-10-26 2009-07-14 51040 Type II

C) 10445904D) 10445888164275

C) 07310MA, 08029MA, 08252MA, 08336MAD) 07177MA, 07311MA, 08043MA, 09077MAKN10, KP08, LA12, LC16, LE15

strepolysin o, or immunoglobulin M analytes.

Tubing disconnecting from the pump inlet of the disposable centrifugal pump during cardiopulmonary bypass.

Engen Automated Sample Handling System Thermo Fisher Scientific OY 2009-10-26 2009-10-06 51117 Type I ENGEN JCT20Q3J Ortho Clinical Diagnostics is aware of one confirmed report of misreported patient results with the Engen Laboratory Automation System. When used with TCAutomation software versions 2.8.2 or below, incorrect sample ID’s may be electronically written to the radio frequency ID tags on the sample carriers.

AdvanSync Orthodontic Device Ormco Corporation 2009-10-26 2009-10-05 51125 Type III 600-4000 080901333, 080902356, 070981416, 060971299, 060976084, 080902357, 080901335, 070981417, 060971304, 060976079

Five complaints involving braze joint failures of AdvanSync Telescopic Rod Assemblies resulting in a recall.

Dimension Vista System-Urea Nitrogen Assay

Lexicon K-FileNeptune 2 Ultra Rover

Siemens Healthcare Diagnostics Inc.

Dentsply Tulsa Dental Specialties Trading As Dentsply EndodonticsStryker Instruments

2009-10-26

2009-10-262009-10-26

2009-09-28

2009-09-292009-10-06

51016

5101751120

Type III

Type IIIType II

K1021

KF010250702-001-000

09187AA

811000105>10 Numbers, Contact Manufacturer

Received customer complaints regarding inaccurate results with the Bun Flex Reagent cartridge lots 09154AE and 09187AA.The test results may be falsely depressed or elevated.

The product is labelled as 25 mm in length but the files are actually 31 mm in length.The company has become aware that there is the potential that over time, a buildup of surgical waste on the receptacle bearing surfaces may increase the force required to rotate the suction manifold. If the force becomes too high the manifold cannot be rotated - therefore it cannot be inserted or removed. Once this occurs there will be no vacuum applied to the suction manifold so the primary function of the affected rover canister is lost.

Amplatz PTFE-Coated Guidewire Gyrus Acmi, Inc. 2009-11-09 2009-08-25 50973 Type III 13BX 96158DB Amplatz PTFE-Coated Guidewires, part number 13BX, sold as lot 96158DB, may have been mis-packaged with product from lot number 96159DB. In this case, the outer box is labelled with the errant 96158DB lot number while the inner pouches are correctly labelled as lot 96159DB.

Endoclamp Aortic CatheterRevlite

Edwards LifesciencesHoya Conbio

2009-11-092009-11-09

2009-10-012009-03-31

5111849248

Type IIType III

EC1001N/A

>10 Numbers, Contact ManufacturerRL-1094

Possibility of the balloon rupturing during use.Advisory letter was sent to customers of Revlite System with Revision E1 software,

Equalizer Balloon Catheter Boston Scientific Cork Ltd. 2009-11-09 2009-09-30 51119 Type II M001171060, M001171080, M001171100, M001171120

>100 Numbers, Contact Manufacturer

declaring that if PTP keypad is pressed while the wavelength window is green, the system may not complete change to new wavelength as requested. Sterile barrier in the packaging of the affected product may be compromised. It has been reported that the outer pouch seal may be breached.

Manual Pulmonary Resuscitator (MPR)

Bryan Cervical Disk System

Unomedical Inc.

Medtronic Sofamor Danek USA, Inc.

2009-11-09

2009-11-09

2009-10-08

2009-10-09

51151

51184

Type I

Type II

724-E

6470114, 6470115, 6470116, 6470117,

03-25

>10 Numbers, Contact Manufacturer

On some units of the Manual Pulmonary Resuscitator (MPR), the duckbill valve and retention ring inside the patient valve housing may become dislodged and fall into the MPR bag/body. If this were to occur, the MPR may loose its ability to generate the positive pressure necessary to function properly. There is a slight possibility of outer pouch failure during shipping, which could result in the

A) Screwplant ImplantsB) Screwplant Healing CollarsC) Legacy Healing CollarsD) Screwindirect ImplantsE) Screwplus Implants

Implant Direct LLC 2009-11-09 2009-08-18 50598 Type II

6470118

A) N/AB) N/AC) N/AD) N/AE) N/A

A) > 100 Numbers, Contact ManufacturerB) > 10 Numbers, Contact ManufacturerC) > 10 Numbers, Contact ManufacturerD) > 10 Numbers, Contact ManufacturerE) > 10 Numbers, Contact Manufacturer

introduction of an inner pouch having non-sterile outer surfaces into the sterile field. The innermost packaging has been shown to remain intact. Proper dispensing technique must be followed, placing the product, rather than the inner pouch, into the sterile field.

Cover caps exhibited visible cracks post sterilization. Testing indicates the integrity of the packaging was maintained by an inner o-ring seal. The date range of distribution for the affected products is 2007/04/26 to 2007/08/01.

(L)50278014 marked as 6mm and the actual 6mm Aimer is marked as 4mm.A) TCD Drainage CathetersB) SKATER Single Step Drainage Set

PBN Medical Denmark A/S 2009-11-09 2009-09-22 51091 Type II A) 716084020B) 756007025, 756008025, 756010025, 756012025, 756506025, 756507025, 756508020, 756512020

A) >10 Numbers, Contact Manufacturer B) >10 Numbers, Contact Manufacturer

Packaging integrity may be compromised as a result of transportation and distribution of the products.

Contour SE Microspheres Boston Scientific Corporation 2009-11-09 2009-08-28 50810 Type II M001761101, M001761122, M001761141, M001761162, M001761201, M001761222, M001761241, M001761262, M001761301, M001761322,

>100 Numbers, Contact Manufacturer All affected product is packaged within a vial. Boston Scientific has determined that, for affected products, the sterile barrier in the packaging (pouch) that contains the vial may be breached.

M001761341, M001761362, M001761401, M001761422, M001761441, M001761462,

Maquet Hanaulux Model Blue 130 Maquet S.A. 2009-11-09 2009-09-22 50980 Type III

M001761501, M001761522, M001761541, M00176156256077943 00001717, 00001719 There is potential for a crack on the front pivot of the Acrobat 2000 spring arm installed with

a Blue 130 series surgical light that could cause the surgical light to swing freely. Defect rate is 0.35%.

Guider Softip Guiding Catheter Medi-Tech Boston Scientific Corporation 2009-11-09 2009-10-07 51219 Type II 10042, 10043, 10044, 10046, 10047, 10048, 10050, 10051, 10052, 10062,

>10 Numbers, Contact Manufacturer It is believed that vast swings in environmental conditions can impact catheter products over time. Improper storage may cause polymer degradation in portions of the catheter. Use of

10063, 10064, 10142, 10143, 10144, 10146, 10147, 10148, 10150, 10151, 10152, 10162, 10163, 10164

degraded catheters can expose patients to potential adverse events including a delay in procedure time due to catheter exchange, vessel trauma and stroke. Boston Scientific Corp. is issuing a safety alert reminding users to follow directions for use.

Syngo Imaging XS Siemens AG 2009-11-09 2009-10-13 51220 Type III 104 96 279 1225, 1532, 1533 A potential of a single image of a series is displayed "distorted" after loading to a viewing application.

Syngo Imaging XS

Heater Wire Adaptors

Siemens AG

Fisher And Paykel Healthcare Ltd.

2009-11-09

2009-11-09

2009-10-13

2009-07-23

51221

50850

Type III

N/A

075 020 29

N/A

14630

N/A

Potential loss of single image data of prior examinations when archived to network-attached storage (NAS) or hierarchical storage management (HSM). After further review it has been determined that this action by the manufacturer is not

Updated recall # 50850 previously posted on 2009-10-12.

considered a recall under the definition of recall, but is considered a product withdrawal by the manufacturer.

Midas Touch Needle Electrode Olsen Medical 2009-11-09 2009-09-24 51204 Type II 30-1014 011668, 011970 The recall was initiated due to recent tests that indicated some Midas Touch Needle Electrodes with modified tip might have an insulation breach and could generate a risk of superficial burn to the patient and/or end-user.

Wallach LL 100 Cryosurgery Device Cooper Surgical Inc. Also Trading As Wallach Surgical Devices 2009-11-09 2009-09-19 51212 Type II REF-900000-900002, REF-900034, REF-900509-5

>10 Numbers, Contact Manufacturer Under certain circumstances a restriction of the flow of carbon dioxide gas within the handle may result in a less than optimal temperature delivery to the treatment site.

Von Willebrand Reagent Siemens Healthcare Diagnostics Products GMBH 2009-11-09 2009-10-13 51218 Type III OUBD23 537675, 537682 An incorrect sensitivity limit has been assigned which is reagent specific and could cause results to be erroneously elevated between 17% and 40%.

XIO Radiation Treatment Planning System

A) Acuson Antares Software Version 4.0

Computerized Medical Systems, Inc. (DBA CMS, Inc.) The Elekta Group

Siemens Medical Solutions USA, Inc.

2009-11-09

2009-11-09

2009-10-13

2009-10-08

51241

51249

Type II

Type III

N/A

A) 05936518

Release 4.3.0 & Higher

A) 112267, 10134

If an auto port is created for a beam on focal, the plan sent to XIO and the beam edited, it is possible the graphic beam representation and dose display do not agree with the edited field on the text page.Potential software problem with Acuson and Sonoline Antares systems product version 5.0

B) Acuson Antares Main Unit/5.0 UpgradesGoldmann Applanation Tonometer Prism Haag-Streit, AG 2009-11-09 2009-10-13 51262 Type III

B) 100327461000855

B) 114573, 113469>100 Numbers, Contact Manufacturer

with cardiac option installed below software version 200.0.079. In Europe, Hagg-Streit received 3 reports concerning leaking Tonometer Prisms. A known reason of failing Tonometer Prisms is the use of disinfectants not approved and not released by Haag-Streit, mainly cool wipes. This might lead to irritation of cornea and in rare cases to reversible corneal erosions.

Gammacoat Plasma Renin Activity 123I RIA Kit Diasorin Inc./S.R.L. 2009-11-09 2009-10-19 51278 Type II N/A 123574, 123612, 123620 The Renin Activity Control provided with the kit has an incorrect range printed on the label. Printed range on the label is 5.5 - 10.3 ng/ml/hr. The correct range is 4.0 -7.6 ng/ml/hr.

Syngo Dynamics C.S.A.N.-5.X,6.X,7.0

A) Voluson E8 Ultrasound System Main UnitB) Voluson E8 Expert Ultrasound System

Siemens Medical Solutions USA, Inc.

GE Medical Systems Kretztechnik GMBH & CO OHG

2009-11-09

2009-11-09

2009-04-30

2009-10-21

48348

51227

Type III

Type III

100 90 480

A) H48651PTB) H48661N

92241, 95243, 93477, 95071, 95248

A) S/N D00229B) S/N D04842, D05589 & D50233

To inform customers about a potential issue, when receiving the multiple PSV measurements from some ultrasound systems, the absolute value is not being used. When using combination of 2D-compound resolution imaging (CRI) and a pulsed wave Doppler single gate (PW) with steered Doppler angle, the displayed velocity scale is

Intertan Hex Screw Smith & Nephew, Inc. 2009-11-09 2009-10-15 51245 Type III 71642220 >10 Numbers, Contact Manufacturerincorrect, which could delay treatment. This recall was initiated as the product description included the word 'captured' and this was

A) Artiste Syngo RT Therapist AssistB) Artiste Syngo RT Therapist

Siemens Medical Solutions USA, Inc. Oncology Care Systems

2009-11-09 2009-09-23 51246 Type III A) 08162807B) 08162815

A) 10024B) 10040

not a 'captured' screw. This could cause intra operative confusion due to the mislabeling. The problem originated in 2007 and all internal product was corrected, however the product in the field was not corrected.Fractions delivered on the Artiste might not be recorded in Lantis and subsequently patients might be mistreated.

IW900 Series Infant Warmer Fisher And Paykel Healthcare Ltd. 2009-11-09 2009-09-07 51309 Type III IW910, IW920, IW930, IW932, IW934, IW950,IW980, WITH SUFFIX JEU

All Infant Warmers in Canada. Notifying users in Canada of updating cleaning instructions for the IW900 Series Infant Radiant Warmers. The inclusion of the recommended and non-recommended proprietary cleaning products supplements the current operating instructions and technical manual held

070 Neuron Delivery Catheter Penumbra Inc. 2009-11-09 2009-09-17 51330 Type II N/A >10 Numbers, Contact Manufacturer

by Canadian customers which already cautions against using solutions containing specifically named chemicals. Design modifications were made to the Neuron Delivery Catheter in March 2009 to improve the catheter kink resistance. Penumbra initiated voluntary field removal of the original

BCI 9015 4-Channel Analog Output Cable Smiths Medical PM, Inc. 2009-11-09 2009-10-19 51331 Type III 9015 W72407catheter design from the marketplace. When interfaced via A 9015 cable to an external data collection device, A 9004 monitor configured with CCAP 1.13 software will not communicate reliably through either channel 3

Endo Femoral Aimers Smith & Nephew, Inc., Endoscopy Division 2009-11-09 2009-09-22 50942 Type I 72201714, 72201716 For product code 72201714: (L) 50278012For product code 72201716: (L)502780141 and

or 4. This issue only occurs when the monitor's analog output is set to external.

Specific product codes and lot numbers of the Endo Femoral Aimers may have been improperly marked indicating the wrong size and part number. The actual 4mm Aimer is

Steinmann Pin Zimmer Inc. 2009-11-23 2009-10-23 51411 Type III 18700259 61211489 This action is being conducted because packages from the identified lot should contain style 5 (trocar-style three point) Steinmann pins. However, they actually contain style 6 (spade-type diamond point).

Therascreen K-Ras Mutation Kit DXS Ltd. 2009-11-23 2009-09-23 50937 Type III KR-41 DK146-01, DK149-01 The mixed standard component of the Therascreen Mutation Kit may sporadically generate out-of-range high results when tested with the control assay.

A) Triporteur Star 3B) Quadriporteur Star 4

Orthofab Inc. 2009-11-09 2009-09-22 50934 Type II A) 180-32040-22B) 180-32000-07, 180-32000-22

A) >10 Numbers, Contact Manufacturer B) >10 Numbers, Contact Manufacturer

Lack of surface treatment on one of the gears of the transmission gearbox.

TheraScreen K-Ras Mutation Kit

A) Online TDM Gentamicin for Roche/Hitachi

Roche Diagnostics GMBH

Roche Diagnostics GMBH

2009-11-09

2009-11-09

2009-09-23

2009-10-07

50937

51194

Type III

Type II

5366259190

A) 03800504190

DK146-01, DK149-01

A) >10 Numbers, Contact Manufacturer

The mixed standard component of the Therascreen Mutation may sporadically generate out-of-range high results when tested with the control assay.The online TDM Gentamicin assays may generate falsely elevated control and patient

B) Online TDM Gentamicin (GENT2) for Cobas

pRK(Rabbit Kidney) Diagnostic Hybrids, Inc. 2009-11-09 2009-01-21 51217 Type III

B) 04490843190

48-0600

B) >10 Numbers, Contact Manufacturer

480109

results when used with the current lot of Preciset TDM 1 Calibrator on the Roche/Hitachi analyzers. The Rabbit Kidney Culture(pRK), which consisted of a monolayer culture of rabbit kidney

Gynecare Morcellex Tissue Morcellator

IW900 Series Infant Warmer

Ethicon Inc. Also Trading As Ethicon Women'sHealth And Urology

Fisher And Paykel Healthcare Ltd.

2009-11-09

2009-11-09

2009-10-09

2009-09-07

51327

51383

Type II

Type III

MX0100

Series With Suffix > IW910, IW920,

>10 Numbers, Contact Manufacturer

All Infant Warmers in Canada.

cells used to grow viruses from a patient specimen in order to detect or identify the virus, appeared to also contain another type of cells. Ethicon is conducting a voluntary product recall of all lots of Gynecare Morcellex Tissue Morcellator due to the potential for the duckbill seal to become dislodged, and a confirmed event in which the seal was retained in a patient.Notifying users in Canada of an updated test procedure for the power-fail alarm of the

IW930, IW932, IW934, IW950, IW980 IW900 Series Infant Radiant Warmer. The service manual already includes a requirement for an annual check of the power-fail alarm. The test procedure has been revised to check

Systeme PhD EIA/IFA (cat# 426-0246) Bio-Rad Laboratories Diagnostics Group 2009-11-09 2009-10-13 51252 Type III 4226-0228, 426-0246 N/A

that the power-fail alarm operates for at least 12 minutes. The revised test procedure accounts for any unexpected degradation over time of the supercapacitor that operates the power-fail alarm. Results passed on integrating lab systems may be erroneous when using competitive tests,

Insight Software Revision H,Bioview REV5.5.1 Sandhill Scientific Inc. 2009-11-23 2009-02-23 47672 Type III S98-1925-2H All lots are affected if they are located outside of the standard range. The Revision "H" software calculated esophageal amplitudes incorrectly when the user generated a report. There were no issues with the acquisition of the data. Users could still acquire data, however there was a requirement to install the revision 'I' software upgrade

A Locus High Resolution SSP Unitray Invitrogen Corporation 2009-11-23 2009-07-24 51366 Type III 47290-10, 47291-10 1145687before reports were printed to ensure data was reported (printed) correctly. Lane 23 in the 'A' high resolution SSP Unitray, lot and batch number identified, will produce a false positive band at the correct base pair size in the presence of A*0301 samples. This will affect typing results on samples that are Aa*0301 homozygote, since they could be erroneously reported as A*0301/A*1101.

Recon Plate 8 X 9mm, 3.5mm

Periarticular Locking Plate System

Smith & Nephew, Inc.

Zimmer Inc.

2009-11-23

2009-11-23

2009-10-14

2009-10-20

51369

51408

Type III

Type III

7114-0108

00-2357-009-06

L06MT04447, L08ET19936

60594607

Smith & Nephew was made aware that all parts were missing the laser etching as identification information.This action is being conducted because the part number on the locking plate (Zimmer Periarticular Locking Plate System distal lateral tibial plate) is incorrect. The part was etched

A) PDS II Absorbable SuturesB) Coated Vicryl Absorbable Sutures

Ethicon Inc. 2009-11-23 2009-10-26 51428 Type II A) Z316HB) J318H

A) ACM008B) ACM473

as '2357-09-07', when it should have been etched '2357-09-06'. Specific lots of PDS II (polydioxanone) Absorbable Sutures are being recalled because some of these products may have a small void in the foil outer package. The void in the foil may lead to suture degradation and the potential for a compromise in the sterility of the product.

ASP Automatic Endoscope Reprocessor Advanced Sterilization Products, A Division Of Ethicon

2009-11-23 2009-09-28 51459 Type III 20300, 20301 >10 Numbers, Contact Manufacturer Advanced Sterilization Products (ASP) is sending a letter to all Automated Endoscope Reprocessor (AER) customers to reinforce the importance of properly setting the disinfectant cycle time when using the ASP AER and to remind users to observe the illuminated temperature light during the cycle. ASP has received user reports about

Apexpro Telemetry System - Clinical Info. GE Medical Systems Information Technologies 2009-11-23 2009-10-26 48250 Type II 418779-010, APRSRVR16=XXX, >100 Numbers, Contact Manufacturerimproper times set for each disinfectant cycle. Operator's manual does not warn against the unintended use of Apexpro Telemetry to

Heartmate XVE And II LVAS Battery Clip Thoratec Corporation 2009-11-23 2009-10-14 51438 Type II

CICV3APRO=XXX, CICV3APRO=XXX/XXX , CICV4APRO=XXXN/A >100 Numbers, Contact Manufacturer

monitor SPO2 without concurrent ECG monitoring and does not identify correct alarms and messages during loss of SPO2 data condition.

The threaded connector of the battery clip housing can become loose from the battery clip housing thereby creating a potential to interrupt pump function.

Reflex Hybrid Screw Extractor Inner Shaft Stryker Spine SAS 2009-11-23 2009-10-13 51370 Type II 48511905B, 48511905D All lots The Reflex Hybrid Screw Extractor Inner Shaft was reported to fail at the threaded tip and fracture in the head of the screw. There had been reports of the threaded tip of the inner shaft being left in the screw due to the surgeon being unable to remove the screw. There had also been reports of damage to the screw and/or the plate while attempting to remove

Trinest Microplate Incubator And Shaker Wallac OY 2009-11-23 2009-10-21 51375 Type II 1296-0050 12960024, 12960028the screw. The protective coating around certain electrical wires inside the Trinest Incubator/Shaker may be worn out due to contact with a round aluminum part rotating during the continuous shaking movement, which would result in a warning message and the instrument would shut down.

Bard Magnum Core Tissue Biopsy Needle

Innova 2121IQ Bi-Plane Cardio Imaging

Bard Peripheral Vascular, Inc.

GE Medical Systems SCS

2009-11-23

2009-11-23

2009-10-16

2009-10-30

51391

51374

Type II

Type II

MN1610, MN1613, MN1616, MN1620

S18821AM

>10 Numbers, Contact Manufacturer

S/N 553918BU4

Some of the needles may exhibit an exposed sample chamber due to extended stylet length from a loose hub connection, resulting in an inability to obtain the biopsy sample.Potential limit switch failure could occur due to collision between lateral plane of Innova positioner and other equipment, which may break x-ray and positioning switches and may

Titan Anchor Accessory Kits Medtronic Inc. 2009-11-23 2009-10-27 51434 Type II 3550-39 >100 Numbers, Contact Manufacturer not allow exam completion. Medtronic has initiated a field action to notify managing and implanting physicians of Medtronic per cutaneous leads for spinal cord stimulation of the potential for separation of the titanium insert from the silicone portion of the Titan Anchor, model 3550-39. If this occurs it may result in lead migration and compromised therapy for the patient.

F) Kinair IVG) V.A.C. ATS Therapy UnitH) Proficare Pump UnitI) Therapulse ATP

F) 216050G) M8259994H) M8259988I) 227080.S, 227800

F) N/A G) N/AH) N/AI) N/A

Staphytect Plus/Dryspot, Test Kits Remel Europe Ltd. 2009-12-07 2009-07-09 50862 Type II DR0100M, DR0850M J577910, J055610, J539110, J610610 A potential for false positive reactions with some non staphylococcus aureus strains.

A-Dec Decade Plus 1221 Dental Chair

Complement Control Cells

A-Dec, Inc.

Immucor Inc.

2009-11-23

2009-11-23

2009-04-06

2009-10-26

51399

51502

Type III

Type III

1221

N/A

>10 Numbers, Contact Manufacturer

32616

When the chair back was returned up to the 'patient entry / exit' position, a pinch existed between the moving chair back support and the stationary underside of the armrest.

There is evidence of potential microbial contamination in some vials of complement control

Synex II System - Central Body Synthes (Canada) Ltd. 2009-11-23 2009-09-23 50981 Type I 04.808.001, 04.808.002, 04.808.003, All lots cells (lot # 32616), based on gram stain results.Synthes (Canada), Ltd. was notified by their supplier, Synthes (USA), of six complaints

Updated recall # 50981 previously posted on 2009-10-12.

Advantage, 2-Button Turbo Handpiece Linvatec Corporation D.B.A. Conmed Linvatec 2009-12-07 2009-11-09 51507 Type II

04.808.004, 04.808.005, 04.808.006, 04.808.007, 04.808.008, 04.808.009, 04.808.010, 04.808.011 D9924 >10 Numbers, Contact Manufacturer

reported outside the US associated with Synex II Implant (Central Body) which fully or partially collapsed in the original implant position after a period of six to fifteen months post operatively. The manufacturer has determined there is a remote possibility that the device may self activate.

Advent 4.5mmd Platform Tapered Abutment Zimmer Dental Inc. 2009-12-07 2009-11-06 51588 Type II AVACT 61233652, 61238956, 61245049, 61252577, 61256798, 61263053, 61314067, 61341224

Zimmer Dental has received field complaints reporting that during application of torque to the abutment, the upper portion of the abutment had fractured and separated from the lower shaft. The investigation has determined that the product is not manufactured to specification. The pilot broach for threading the internal threads of the implant is too deep

Remstar M Series Heated Humidifier Respironics Inc. 2009-12-07 2009-11-20 50202 Type II 1049109, 1049110, 1049124, 10499110, 1051157, 1051158, R1049109,

>10 Numbers, Contact Manufacturer and extends into the shaft of the screw. Some humidifiers may fail to operate due to potential malfunction of the internal connection between the heated plate and the printed circuit board which results in a 'blinking blue light'

Centricity PACS Workstation - Software GE Healthcare IT 2009-12-07 2009-10-30 51228 Type II

R1049110, U1049109, U1049110

K2020YS, K2030JN >100 Numbers, Contact Manufacturer

on the humidifier control knob.

If Dicom node config. is set to accept, user may unintentionally add new images to an approved exam, under certain conditions images will be deleted from PACS or from dictated, transcribed or completed status exam.

CyberKnife Robotic Radiosurgery SystemUpdated recall # 50252 previously posted on 2009-08-31.

Accuray, Inc. 2009-12-07 2009-06-22 50252 Type II 28000 C202 A healthcare facility reported their end-to-end targeting accuracy was out of specification. The position of one of the robotic manipulator axes differed from the position determined by the robotic controller. Error 103 (karel e-stop detected) and error 342 (Deviation in absolute

Colleague Volumetric Infusion Pumps Baxter Healthcare Corporation 2009-12-07 2008-11-24 44735 Type III 2M9163 >10 Numbers, Contact Manufacturer

position value DSE - RDC) were displayed. Recalls 50114 and 50252 are identical. For future reference, refer to recall 50252. Customers were erroneously provided with version 0719H0166 of the operator's manual

Updated recall # 44735 previously posted on 2008-11-24. Leksell Stereotactic System - Fixation Post

A) Nexgen Rotating Hinge Knee - FemoralB) Nexgen Rotating Hinge Knee - TibialC) Nexgen Rotating Hinge Knee,Tibial Plate D) Nexgen Rotating Hinge Knee - Femoral, B

Elekta Instruments AB

Zimmer Inc.

2009-12-07

2009-12-07

2009-10-02

2009-11-06

51522

51622

Type II

Type III

1003935, 1003937

A) 00-5880-013-01, 00-5880-014-01, 00-5880-014-02, 00-5880-015-01, 00-5880-015-02, 00-5880-016-01, 00-5880-016-02B) 00-5880-002-00, 00-5880-003-00, 00-

N/A

A) >10 Numbers, Contact Manufacturer B) >10 Numbers, Contact Manufacturer C) 60433397, 60461749 D) 60186249 H5

instead of the correct version 0719I0166.

Excessive heating of the tip of the fixation screws with the standard non-insulated posts may cause minor burning of the contact point of patients during certain higher energy MRI usage.

This action is being conducted because these components are labelled with a 10 year expiry period when in fact these components expire 5 years after manufacture. Expiration dating refers to 'use by' dates. There is no risk to patients who receive these implants prior to January 2010, when devices from the affected lots begin to expire.

RET-Search II Sysmex Reagents America 2009-12-07 2009-11-03 51623 Type II

5880-004-00, 00-5880-005-00, 00-5880-006-00C) 00-5880-001-02 D) 00-5880-012-01

RED-700A ZY9021 Several boxes of RET-Search II (Red-700A) manufactured on July 15, 2009 had an

Durom Acetabular Cup Zimmer GMBH 2009-12-07 2009-11-15 51631 Type II 01.00214.044, 01.00214.046, >1000 Numbers, Contact Manufacturer

incorrect bar code label applied to the product box. The bar code label identified the product as stromatolyser-NR with the same lot number and expiration date. The box contains a reagent bottle and dye pouch, both of which were correctly labelled, and the contents of the bottle and dye pouch are of the proper chemical composition for RET-Search II and passed all in-process and final inspection test criteria. There have been reports of revisions of Zimmer's Durom Acetabular Cup and the Metasul

A) Therakair VisioB) InfoV.A.C. Therapy UnitC) First Step All in OneD) ActiV.A.C. Therapy Unit

KCI USA, Inc. 2009-12-07 2009-11-09 51634 Type II

01.00214.048, 01.00214.050, 01.00214.052, 01.00214.054, 01.00214.056, 01.00214.058, 01.00214.060, 01.00214.062, 01.00214.064, 01.00214.066A) M6257763B) M8260027C) 227500D) 340013

A) N/AB) N/AC) N/AD) N/A

LDH (large diameter head) femoral head in certain European markets. Based on Zimmer's investigation, the most probable cause is using a surgical technique which differs from that prescribed in the surgical technique for the Durom Acetabular Cup. This field safety notice updates surgical technique instructions.

Power cords may crack and fail leading to potential risks of electrical shock, delay in setup and therapy, interruption of therapy and fires which may also occur in an oxygen-rich environment.

E) First Step Select - Pump E) 215200 E) N/A

pictures or videos were captured using SDC HD during surgery, however the system date would be incorrect and users would not be able to correct this issue without a software upgrade.

Auto D Dimer Kit CRS 126B Trinity Biotech PLC 2009-12-07 2009-08-19 51650 Type II CRS126-B T065095, T082003, T119007 The response of the two highest points of the kit's calibration curve are the same and consequently very high D dimer values may be underestimated.

A) Accura Breast Localisation NeedlesB) Hawkins II Breast Localisation NeedlesC) Hawkins I Breast Localization NeedlesD) Homer Mammalok Breast Localisation NeedlesE) Manan Co-Axial Introducer NeedlesF) Manan Introducer Sheath NeedlesG) Manan Guidewire Introducer NeedlesH) Manan Seldinger NeedlesI) Manan Modified Potts/Cournand NeedlesJ) Manan Galactography TraysK) Skater-Centesis CatheterL) Chiba Style ManualM) Franseen StyleN) Green StyleO) Spinal StyleP) Westcott Style

Medical Device Technologies, Inc. DBA Angiotech 2009-12-07 2009-09-01 50935 Type II A) N/AB) N/AC) N/AD) N/AE) N/AF) N/AG) N/AH) N/AI) N/AJ) N/AK) N/AL) N/AM) N/AN) N/AO) N/AP) N/A

A) >10 Numbers, Contact Manufacturer B) >10 Numbers, Contact Manufacturer C) >10 Numbers, Contact Manufacturer D) >10 Numbers, Contact Manufacturer E) >10 Numbers, Contact Manufacturer F) >10 Numbers, Contact Manufacturer G) >10 Numbers, Contact ManufacturerH) >10 Numbers, Contact Manufacturer I) >10 Numbers, Contact Manufacturer J) >10 Numbers, Contact Manufacturer K) >10 Numbers, Contact ManufacturerL) >10 Numbers, Contact Manufacturer M) >10 Numbers, Contact Manufacturer N) >10 Numbers, Contact Manufacturer O) >10 Numbers, Contact Manufacturer P) >10 Numbers, Contact Manufacturer

The complaints were reported as "run off" (non-contiguous) seals. A run off seal is a seal in which the Angiotech applied seal is mis-aligned.

Q) Hawkins III Breast Localization NeedlesR) Pro-Mag Disposable Biopsy NeedlesS) Maxi-Cell Biopsy NeedlesT) Ultracore Disposable Biopsy NeedlesU) Lorad Needle Guide

Q) N/AR) N/AS) N/AT) N/AU) N/A

Q) >10 Numbers, Contact Manufacturer R) >10 Numbers, Contact Manufacturer S) >10 Numbers, Contact Manufacturer T) >10 Numbers, Contact Manufacturer U) >10 Numbers, Contact Manufacturer

neoBLUE mini LED Phototherapy System

A) Unicel DXI600 Access Immunoassay System Class 2 B) Unicel DXI600 Access Immunoassay System Class 3C) Unicel DXC880I Access Clinical Analyzer

Natus Medical Inc.

Beckman Coulter Inc.

2009-12-07

2009-12-07

2009-10-01

2009-10-26

51237

51422

Type II

Type II

10101

A) A30260, A71461B) A71461C) 4768D) 973100, A71457E) 973100, A71457

60001-62656 serial number

A) N/AB) N/AC) N/AD) N/AE) N/A

There has been a trend observed in failure of the pole mount clamp shipped with a neoBlue mini LED Phototherapy Systems. When tightened with excessive force, some of these clamps have shown stress fractures or broken. The pole mount clamp has been redesigned by the manufacturer and customers of record are being advised to inspect their systems and to order a replacement clamp if necessary. A software issue was identified in system software 4.2 and 4.2.1, which may result in the incorrect handling of a wash arm dispense plate motion failure. Instead of generating a red 'warning' event and stopping sample processing, the system will post a yellow 'caution' event and continue to operate with the dispense plate in an elevated position until the instrument is reinitialized. Potentially affected results are not flagged.

D) Unicel DXI800 Access Analyzer Class 3E) Unicel DXI800 Access System Analyzer Class 2

F) 4771G) 4772

F) N/AG) N/A

F) Unicel DXC660I Access Clinical AnalyzerG) Unicel DXC680I Access Clinical AnalyzerH) Unicel DXC860I Access Clinical AnalyzerDupaque X-Ray Detectable Sponges Derma Sciences, Inc. 2009-12-07 2009-10-27 51464 Type II

H) 4773

94675-5

H) N/A

4408 Received two complaints from a customer indicating that the sponge separated at the end

A) Artiste MV-Syngo RT Therapist AssistB) Artiste MV-Syngo RT Therapist

Siemens Medical Solutions USA, Inc. Oncology Care Systems 2009-12-07 2009-11-05 51605 Type III A) 08162807B) 08162815

A) 10024B) 10040

during surgery and was left behind.Two or more treatment plans with different ISOcenter positions are stored together in one course in Lantis, e.g. main treatment plan and boost plan. If the cone beam is acquired using calculation of table shift coordinates will be based on ISOcenter position. This will lead

Medical Grade Flat Panel Display Spacelabs Medical, Inc. 2009-12-07 2009-10-30 51662 Type II 94260-19 >10 Numbers, Contact Manufacturer to an incorrect table shift. A potential safety hazard associated with the use of Spacelabs Medical 19" Flat Panel Displays, model 94260-19. There is a possibility that the internal power distribution circuit

Vertical Surgical Table

Medfusion Syringe Infusion Pumps

Stryker Communications

Smiths Medical MD Inc.

2009-12-07

2009-12-07

2009-11-06

2009-11-16

51664

51668

Type II

Type II

0788-100-000, 0788-100-001, 0788-100-0015

3010A, 3500-306, 3500-415, 3500-500

All Lot Numbers

>100 Numbers, Contact Manufacturer

board will fail prematurely, causing the display to go blank. Audio alarms will continue to function normally.The table may experience involuntary movement as a result of fluid intrusion. This hazard can arise especially when the table is in the trendelenburg or anti-trendelenburg position allowing fluids, such as saline or water, to enter the table column.Smiths Medical has become aware of an increased trend in reports of "motor not running" ("MNR") and "motor rate error" ("MRE") alarm message events with certain Medfusion Syringe Infusion Pumps, models 3010a and 3500 ("pump"). These are high priority alarm messages which can occur for a variety of reasons as part of the usual self-test functionality of these pumps. The pump stops delivery when an MNR/MRE alarm message event occurs.

Bioflex 2200- 665-1850 Vasculitis Kit Bio-Rad Laboratories Diagnostics Group 2009-12-07 2009-11-06 51677 Type II 6651850 950759, 959261, 961363 Bioplex 2200 vasculitis reagent kits could produce false results when analyzing diluted samples.

Getinge Steam Sterilizer

Leksell gamma Knife Perfexion

A) SDC HD Capture RecorderB) SDC HD Capture Device

Getinge Sourcing LLC.

Elekta Instruments AB

Stryker Endoscopy

2009-12-07

2009-12-07

2009-12-07

2009-09-01

2009-08-18

2009-10-30

50976

51437

51583

Type II

Type II

Type II

422HC, 433HC, 522HC, 533HC, 633HC, 733HC, 833HC

715000

A) 240-050-888 B) 240-050-890

>10 Numbers, Contact Manufacturer

Serial Number 6005

A) All Lot Numbers B) All Lot Numbers

RTD temperature sensor component was failing prematurely. Temperature control of the sterilization process is maintained through the use of the sensor used in the sterilizer jacket and chamber. When incorrectly used the frame adapter may become damaged which in worst case could make it possible to lock the adapter so it does not properly fixate the frame. Stryker Endoscopy was aware that the SDC HD picture/video capture device would not be able to assign the correct time/date stamp for saved files after December 31st 2009. On January 1st 2010, the system date for all SDC HD units would re-start from October 1st 2001 and begin incrementing from that point onwards. This event would not affect how

Varis 4D Integrated Treatment Console Varian Medical Systems, Inc. 2009-12-07 2009-10-16 51774 Type II 8.0.12, 8.0.23 SP2 , 8.1 SP2, 8.1.1.3, 8.1.1.4,8.1.2, 8.1.3, 8.1.4, 8.3, 8.6, 8.6.1, 8.6.2, 8.8.0, H51

>10 Numbers, Contact Manufacturer Malfunction when adding CBCT image. Present software has ability to acquire gantry angle when 'treatment approval enforced' and/or 'allow only couch parameter (vert, long, lat) editing & acquiring for approved plans' selected in treatment administration. Therapists can acquire gantry angle into plan, even without system rights to acquire gantry angle. Patient treated with wrong gantry angles one day.

Removable Magnet Hires 90K Advanced Bionics, LLC 2009-12-07 2009-08-25 51652 Type II N/A N/A Advanced Bionics (AB) is notifying all surgeons, clinicians and patients that the removable magnet component of the HiRes 90k cochlear implant (model no. CI-1400-01 and CI-1400-02H) is susceptible to corrosion. The affected units should be monitored and replaced if

BHR Streamline Cup Introducers Smith & Nephew, Inc. 2009-12-07 2009-11-11 51665 Type II 90128285 S811270necessary. The identified lot number may mechanically seize up, preventing release of the cable tightening mechanism, during surgery or before use. As a result, this could prolong surgery time. Also, if implanted, this could cause a possibility of malpositioning of the cup due to use of the device in a mechanically seized condition.

A) Intravenous Infusion Accessory IVMED20B) Intravenous Infusion Accessory IVMED60

Medxl Inc. 2009-12-07 2009-11-06 51696 Type II A) N/AB) N/A

A) N/AB) N/A

A warning letter was sent to the distributor requesting that sales be suspended until a licence has been obtained.

A) Access Immunoassay System - TroponinB) Unicel DXI600 Access Immunoassay SystemC) Unicel DXI800 Access Immunoassay System

Beckman Coulter Inc. 2009-12-07 2009-10-23 51585 Type III A) A78803B) A78803C) A78803

A) 915417B) 915417C) 915417

The reagents in wells three (RLC) and four (RLD) of the reagent pack were inadvertently switched during manufacturing. Lot number 915417 contains reagent RLD in well three and RLC in well four.

Triniclot PT Excel, T1106 Trinity Biotech PLC 2009-12-07 2009-08-06 51651 Type III T1106 S172057 Quality control materials not recovering within predefined ranges. Prothrombin times are prolonged in lot S172057 by about 1.2 seconds.

Galileo Echo Blood Bank Analyzer Immucor Inc. 2009-12-07 2009-11-06 51706 Type I 87000 N/A Two lot numbers of reagents or strips are allowed to be tested while performing QC testing

Galileo Echo Blood Bank Analyzer Immucor Inc. 2009-12-07 2009-11-06 51708 Type I 87000 N/A

on the echo. The result is that the final lot tested will pass QC even though it did not undergo complete QC testing. Under some circumstances, a manually entered sample ID could be assigned to the wrong

Oxidase Touch SticksKryptonite Bone Cement

A) Signa 1.5T Excite HD - GradientsB) 3.0T Signa HDX MR System - Main UnitC) 1.5T Signa HDX MR System - HardwareD) Discovery MR750 MR System - Main UnitE) 1.5T Signa Infinity Twinspeed ExciteF) Signa 1.5T Infinity Excite MR System

Oxoid LimitedDoctors Research Group Inc.

GE Medical Systems LLC

2009-12-072009-12-07

2009-12-07

2009-07-072009-09-17

2009-11-05

5173751492

50777

Type IIType III

Type II

BR0064AKRYP-X-03, KRYP-X-10, KRYP-Z-03, KRYP-Z-10

A) M3000LFB) M3335JKC) M3335PBD) M7000BFE) M3000TDF) 2294302

70207905072009, 05272009, 06292009, 03102009, 07142008, 10232008, 10272008, 10312008, 10282009A) HDMR10368, 7547YR3, 278606MR9, 266072MR8, 274168MR4, 270572MR1B) 7555YR6C) >10 Numbers, Contact Manufacturer D) 291192MR3, 290992MR7E) >10 Numbers, Contact Manufacturer

sample. May produce weak positive or false negative results. As a result of increased viscosity of component "A" in some Kryptonite Bone Cement Kits, the end user may observe difficulty in discharging component "A" from the syringe that it is packaged in. Use of CADstream with "pure" software for Dynamic MRI imaging may require a modification to the study preference settings to present colour overlays equivalent to non-pure studies.

G) Signa Excite 3.0T ElectronicsH) Signa HDXT 1.5T MR System - Main Unit

G) M3333TAH) SIGNA HDXT 1.5T MR SYSTEM

F) 243409MR0, 239046MR6, 253630MR8, 239043MR3, 256216MR3, 246610MR0, 258415MR9, 247728MR9, 242181MR6G) 6690YR2, 266690MR7H) 30BD4960

Signa HDE 1.5T MRI System - Magnet

Dimension V-Lyte Integrated Multisensor

A) Unicel DXC600I Synch.Acc.Clin. AnalyzerB) Unicel DXC880I Synch.Acc.Clin. AnalyzerC) Unicel DXC660I Synch.Acc.Clin. AnalyzerD) Unicel DXC680I Synch.Acc.Clin. AnalyzerE) Unicel DXC860I Synch.Acc.Clin. Analyzer

GE Healthcare Japan Corporation

Siemens Healthcare Diagnostics Inc.

Beckman Coulter, Inc.

2009-12-07

2009-12-07

2009-12-07

2009-11-05

2009-10-29

2009-10-22

51766

51421

51584

Type II

Type III

Type III

M3335SE

K800, K820, K825, K835

A) 4767B) 4768 C) 4771D) 4772E) 4773

HDMR2675, 9948YR1,10833YR2, 11827YR3, 8704YR9, 10685YR6, 7964YR0, 10023YR0

>10 Numbers, Contact Manufacturer

A) Cup Lot Numbers Starting With "09" Or LaterB) Cup Lot Numbers Starting With "09" Or LaterC) Cup Lot Numbers Starting With "09" Or LaterD) Cup Lot Numbers Starting With "09" Or LaterE) Cup Lot Numbers Starting With "09" Or Later

Use of CADstream with "pure" software for Dynamic MRI imaging may require a modification to the study preference settings to present colour overlays equivalent to non-pure studies.Received customer complaints regarding Dimension Vista V-Lyte. Siemens confirms that urine sodium results become elevated as urine specimens are run on a sensor. The access 1.0 ml insert cup, used on Unicel DXC Synchron Clinical Systems, might be the cause of some sample wheel motion errors when run using 13x100 sample tubes.

Buretrol IV Solution Adm.Sets Clearlink

Power Cord Component Of Sesmoid Plasty

Baxter Healthcare Corporation

Zimmer CAS

2009-12-07

2009-12-07

2009-11-05

2009-11-05

51663

51683

Type II

Type II

2C8864

500.923 SUB COMP 200.301

UR09E21238

SP-122, SP-197

Separation of tubing from Distal Clearlink Y-site could occur, which may result in blood loss, infection, interruption of or delay in the start of intravenous therapy.1. Female receptacle end: the terminal contact are not sufficiently recessed and protected

CBC II Blood Conservation Kit Stryker Instruments 2009-12-07 2009-11-13 51764 Type II 225-414-000 >10 Numbers, Contact Manufacturer

from access. 2. The cable portion is not certified North America. 3. The male plug that plug to the power supply mains is missing a label. There is a potential that the package pouch in the CBC II Blood Conservation Kits may have a pin hole, a weakened seal, or an opened seal that could result in the product not being

Kyphx HV-R Bone Cement Medtronic Spine LLC 2009-12-07 2009-11-09 51643 Type II C01A, C01B >10 Numbers, Contact Manufacturer sterile.Medtronic Spine LLC is recalling specific lots of Kyphx HV-R bone cement following complaints regarding extended time to reach the proper viscosity (doughy state) and

Model 7600 - Oximeter Pod Nonin Medical Inc. 2009-12-07 2009-10-23 51731 Type II Model 7600 500849356, 500849358, 500849360, 500549361, 500823174, 500857064, 500874926

inconsistency or lack of homogeneity during cement preparation, as well as when waiting to deliver the bone cement with the delivery device (e.g. bone filler device). A malfunction with one of the components that may result in the overheating of the Oximeter pod has the potential to cause a burn if the pod is in direct contact with the patient.

A) C-Series Clinac, Trilogy & Novalis Tx B) Trilogy Radiotherapy Delivery SystemC) Novalis TX Linear Accelerator

Varian Medical Systems, Inc. 2009-12-07 2009-10-08 51773 Type II A) H18, H27, H29B) H14, H29C) H14, H29

A) >10 Numbers, Contact Manufacturer B) >10 Numbers, Contact ManufacturerC) >10 Numbers, Contact Manufacturer

SRS treatments occurred with conical collimator accessory not inserted, or with conical collimator accessory correctly mounted, but with a primary collimator field size setting exceeding outside diameter of that conical collimator. With wrong field size, unintended radiation is given to patient outside the outer edge of cone.

lot 9ED058 vs. 9BD064. Siregraph CF Siemens AG 2009-12-21 2009-10-08 51376 Type III 04 98 717 1987, 3089 The potential hazard of fingers or hands getting caught exists when the patient holds on to

the tomographic rod between the column/tube assembly and the spotfilm device.MRSASelect Referance 63747 Coffret 20 Plaque Bio-Rad 2009-12-21 2009-10-23 51525 Type II 63747 9H2414, 9H2417, 9H2425, 9J2429, 9J2432,

9J2435, 9J2437Decrease of medium selectivity for methicillin-sensitive Saphyloccus aureus strains before medium’s expiration date.

A) BD Q-Syte Extension SetB) MPS Acadia Extension Set With RightboreC) MPS Acadia Specialty Tri-Extension Set

Becton Dickinson Infusion Therapy Systems Inc. 2009-12-07 2009-11-02 51661 Type I A) 385102B) 385150, 385151C) 385164

A) 8308330B) A1967, A2399C) A1951

Product may function improperly. This may result in the risk of air bubbles leaking into the infusion system through the BD Q-Syte Luer access split septum. This may lead to complications should the air bubbles not be detected.

Tg Gen.2 (Thyroglobulin) Assay Roche Diagnostics GMBH 2009-12-07 2009-11-12 51712 Type II 5118921190 155166 The current lot #155166 of TG Gen.2 (Thyroglobulin) Assay shows a premature ageing effect which leads to a positive bias of approximately 1ng/ml TG when used in combination with all current lots # 151605, 152737, 155488 and 157297 of elecsys thyroglobulin calibrator. The manufacturer has determined that customers should not use it for this purpose anymore.

Duralite Pyramid Receiver Prox. AdaptorSequencer For Mosaiq

The Ohio Willow Wood CompanyImpac Medical Systems Inc.

2009-12-072009-12-07

2009-11-092009-10-16

5174051821

Type IIType II

N/AN/A

All Lot NumbersMosaiq 1.40 (All Builds), Mosaiq 1.41 (All Builds), Mosaiq 1.50

There is a potential for the adapter to crack or break while in use by active amputees.Consolidated field sequencing (CFS) feature not working properly as X2 jaw moved when only the X1 jaw should have been moving.

(All Builds), 1.60 (Up To, Including T2SP4), 2.00 (All Builds)

Triniclot APPT S, Cat. No. T1202

Triniclot APTT HS, Product Code T1204

A) Imager II Angiographic CathetersB) Imager II Catheters BERNC) Imager II Catheters SIMD) Imager II Catheters Contra2E) Imager II Catheters CF) Imager II Catheters RCG) Imager II Catheters RDC

Trinity Biotech PLC

Trinity Biotech PLC

Boston Scientific Corporation

2009-12-21

2009-12-21

2009-12-21

2009-04-23

2009-05-24

2009-11-03

49895

49896

51535

Type II

Type II

Type II

T1202

T1204

A) 31-400, 31-402, 31-510, 31-516, 31-520, 31-602B) 31-407, 31-408, 31-409, 31-410, 31-607, 31-609C) 31-430, 31-631D) 31-458, 31-459, 31-658E) 31-466, 31-467, 31-468, 31-469, 31-

S067009

R324001

A) >10 Numbers, Contact Manufacturer B) >10 Numbers, Contact Manufacturer C) >10 Numbers, Contact Manufacturer D) >10 Numbers, Contact Manufacturer E) >10 Numbers, Contact Manufacturer F) >10 Numbers, Contact Manufacturer G) >10 Numbers, Contact Manufacturer

Precision and open vial stability issues with this lot may result in increased or decreased APTT times across the range of the assay. The lot is not stable for the full 30 day period when opened and stored. Precision issues with this lot may result in increased APTT times across the range of the assay. The sterile barrier in the packaging (pouch) that contains the catheter may be breached. The breach of sterility could lead to a contamination of the device with subsequent transfer of infectious agents to the patient.

H) Imager II Catheters PigtailI) Imager II Catheters Contralateral

669F) 31-485, 31-486, 31-685G) 31-488, 31-489, 31-491

H) >10 Numbers, Contact Manufacturer I) >10 Numbers, Contact Manufacturer

H) 31-509, 31-513, 31-519I) 31-525, 31-528, 31-531

Imager II Urology Torque Catheters Boston Scientific Corporation 2009-12-21 2009-11-03 51536 Type II M0064003031 57271, 57616, 57269, 57613 The sterile barrier in the packaging (pouch) that contains the catheter may be breached. The breach of sterility could lead to a contamination of the device with subsequent transfer of infectious agents to the patient.

Washer Disinfectors

Pronto-Short Extraction Catheter

Getinge Disinfection AB

Vascular Solutions, Inc.

2009-12-21

2009-12-21

2009-04-23

2009-11-20

51707

51819

Type II

Type II

9027, 9100, 9120, 9125, 9128

N/A

>10 Numbers, Contact Manufacturer

Lot 544202, Exp. 11-2009, Lot 545693, Exp. 05-

The ground wire of the supply transformer exhibited signs of high resistance in a complaint and may give high eddy currents. The expiration date of the sterile pouched guidewire was not considered when expiration

Koordinat M/MP Siemens AG 2009-12-21 2009-08-13 50747 Type III 05294003, 06239003

2010, Lot 546614, Exp. 09-2010

>10 Numbers, Contact Manufacturer

dating was calculated for the finished device. Cannot assure sterility or function of the guidewire beyond its expiration date. If the swivel locking mechanism is not completely engaged into position, during patient transfer, the table may unintentionally swivel, could result in uncontrolled patient movement during transfer, patient falling to the floor.

Vitrax II (Sodium Hyaluronate) Advanced Medical Optics, Inc. 2009-12-21 2009-11-06 51828 Type II VT465 >10 Numbers, Contact Manufacturer The Vitrax II product is being recalled because during routine stability testing, it was discovered that a sample tested at the three month time point had a ph value of 7.70 which exceeded the ph specification range of 6.8 to 7.5 resulting in a lab investigation. The investigation revealed that some units from different lots post ETO sterilization have a ph

TECNIS 1-Piece Posterior Chamber IOL Advanced Medical Optics, Inc. 2009-12-21 2009-11-10 51829 Type II ZCB00 N/Agreater than the upper ph limit of 7.5. The highest value was found to be 8.29. The TECNIS 1-Piece Intraocular Lenses (IOLS) are being recalled because the haptics of some TECNIS 1-Piece IOLS (model ZCB00) have adhered to the lens optic after insertion into the eye. This situation can lead to additional manipulation to separate the haptics from the optic during surgery which could lead to an injury.

A) Powerhart G3 Automated External Defibrillator B) Powerhart AED G3 ProC) Powerhart AED G3 Plus

Cardiac Science Corporation 2009-12-21 2009-10-08 51818 Type II A) 9300A-501PPC B) 9300P-601C) 9390E-501

A) 4230260ppcB) 4226121C) 4237595

Review of test records indicated that the seven impacted Powerhart G3 AEDS manufactured by Cardiac Science Corporation (CSC) may not have received adequate testing prior to being shipped from the factory.

D) Powerhart G3 Plus AutomaticE) Powerhart - AED G3 (Biphasic)A) Tegaderm Hydrocolloid Dressing 3M Health Care 2009-12-21 2009-11-23 51873 Type III

D) 9390A-501E) 9300E-501A) 90002

D) 4183220E) 4218441, 4153329, 4153683A) 2012-06 AA The master carton and the individual dressing packages are labelled correctly, however the

B) Medipore Soft Cloth Surgical Tape B) 2961 B) 2012-10 XT boxes that contain the individual dressing packages were labelled for Tegaderm Hydrocolloid thin dressing, catalogue # 90022.

EZManager Max Diabetes Management Software Animas Corporation 2009-12-21 2009-11-16 51762 Type III 100-467-23, 100-467-50 2937776 for EZManager Max CD, French2936068, 2938247, 2962490 for EZManager Max CD, English

Compact discs received for EZManager Max Diabetes Management Software packages were identified as being blank when used in a computer.

OneTouch SureStep Test Strips

A) Navigation Software Knee Zimmer

Lifescan Inc.

Brainlab AG

2009-12-21

2009-12-21

2009-09-24

2009-09-11

51926

50954

Type III

Type III

Part # 010-665

A) 22086-03D, 22086-03E

2749789

A) Version 2.1.1 & All Previous

Expired OneTouch SureStep Test Strips (lot#274789) were shipped to four Canadian wholesalers. Incorrect Zimmer implant data in Brainlab Software Knee leads to incorrect information for

B) Brainlab Knee Essential SoftwareC) Brainlab Knee Unlimited Software

B) 21100-01(2.0), 21100-01C(2.1)C) 70001A, 70002A(2.1)

B) Version 2.1.1 & All PreviousC) Version 2.1.1 & All Previous

Zimmer Innex implants.

Dimension Vista System-Chem Calibrators Siemens Healthcare Diagnostics Inc. 2009-12-21 2009-10-19 51373 Type III KC130 9ED058 Customer complaints regarding Dimension Vista Amon method. Siemens has confirmed a negative bias of up to 35% for level 1 quality control when calibrated with Chem 3 Calibrator

A) Intro-Flex Introducer SetsB) Percutaneous Sheath Introducer Kit

Edwards Lifesciences LLC 2009-12-21 2009-05-21 48857 Type II A) 1350BF85B) I652BF85H, S5507BF85

A) >10 Numbers, Contact Manufacturer B) 58511631, 58549300, 58606253, 58648812, 58496258, 58535112, 58604814, 58644423

Blue connector proximal to Tuohy-Borst hemostasis valve may fatigue, crack or separate, resulting in patency failure & potential blood loss where Intro-Flex Introducer secures a venous catheter.

A) VNS Therapy Demipulse Programmable GeneratorB) VNS Therapy Demipulse Duo Generator

Cyberonics Inc. 2009-12-21 2009-12-03 52025 Type II A) N/AB) N/A

A) All Lot Numbers B) All Lot Numbers

Enhanced labelling to prevent end of service (EOS) warning messages & reduced battery life resulting from electromagnetic induction (EMI), electrostatic discharge (ESD), or electro cautery exposure during surgery.

Rapid Eric Electronic Compendium Remel Inc. 2009-12-21 2009-10-30 51669 Type I RE8323600 1096277 Error limited to the Rapid Yeast Plus Database regarding differentiation of C. albicans from

Excor System-Connecting Set For Cannula Berlin Heart GMBH 2009-12-21 2009-10-02 51703 Type I A06-009, A09-012, A12-016 526337C. dubliniensis potentially leading to false ID of isolate.It was observed that a too short cut of the adapter cannula combined together with certain

Diagnostic Ultrasound Transducers / Probe Toshiba Medical Systems Corporation 2009-12-21 2009-10-30 51870 Type II PVT-681MV >10 Numbers, Contact Manufacturer conditions of stress may have a effect of leakage of the cannula. In ultrasound systems using the Ultrasound Convex Transducer PVT-681MV, the volume

i-CAT 3D Dental Imaging System

Twist Drill 1.1x50mm 3.5mm stop

Imaging Sciences International, Inc.

Walter Lorenz Surgical, Inc. Also trading as: Biomet Microfixation

2009-12-21

2009-12-21

2009-10-30

2009-11-18

51709

51857

Type II

Type III

9140-0000-0000

01-7141

ICU070488, ICU070518, ICU070519

537407, 536306, 535933

image acquired in 'plane C' is reversed horizontally. Fault in the brake system may result in gantry-overhead dropping quickly when the overhead is lowered. i-CAT classic containing electrical brake. Three manufacturing lots of Twist Drill 1.1 x 50mm, 3.5mm stop with J notch, part number 01-7141 were packaged and distributed without the instructions for use.

Carto 3 EP Mapping System Biosense Webster (Israel) Ltd. 2009-12-21 2009-11-25 51915 Type II FG540000 3257, 2246, 4203, 4166, 4184 Biosense Webster, Inc. has recently become aware of a potential hazard that may occur during the operation of the bloom DTU-215b cardiac stimulator (not a Johnson & Johnson device) in conjunction with RF generators and EP equipment, including the Carto 3 system.

i-CAT 3D Dental Imaging System Imaging Sciences International, Inc. 2009-12-21 2009-10-30 51944 Type II 9140-0000-0000 >10 Numbers, Contact Manufacturer

If RF energy and pacing stimuli are delivered simultaneously, across the same electrode pair, a DC voltage may be generated. This can cause micro-bubbles in the blood within the heart chamber. i-CAT classic units containing mechanical brake or containing dual brake system- fault in

Triage Tox Drug Screen PN 94400 Biosite Incorporated 2009-12-21 2009-05-28 50030 Type III 94400 >10 Numbers, Contact Manufacturer brake system may result in the gantry-overhead carriage moving below its limits. Biosite, Inc. initiates notice of correction for Triage Tox Drug Screen Kit, PN 94400. Boxes shipped after August 6, 2008 are misprinted on the right side of the box flap. The misprint incorrectly states "use EDTA whole blood or plasma sample only". The kit is intended for use with urine samples not blood or plasma.

Galileo Echo Blood Bank Analyzer Immucor Inc. 2009-12-21 2009-11-25 51956 Type II 87000 N/A The instrument may generate a negative well interpretation for capture-R ready-screen or capture-R ready-ID assays and subsequent visual interpretation of those reactions are weak positive or questionable (equivocal).

Hintegra Talar Cutting Guides New Deal SA 2009-12-21 2009-10-20 51435 Type II Left Cutting Guide, Right Cutting Guide >10 Numbers, Contact Manufacturer The width of the defective Talar Cutting Guides is too large, thus the medio-lateral cuts are too large compared to the Talar trial implant dimensions.

Amplicor STD Specimen & Transport Kit

BD 30ml Luer-Lok Syringes

Roche Molecular Systems, Inc.

Becton Dickinson Canada Inc.

2009-12-21

2009-12-21

2009-11-27

2009-11-26

51858

51921

Type II

Type II

20753920122

309650

K13333, K13334, K15491, K15492, 2036

9175046

Potential for the male swab to present a defectiveness where the cotton head of the swab may dislodge and/or unravel with minimal force. This could result in having cotton fibres remaining within the urethra during specimen collection of male patients.BD has determined that a small number of unit packages may have open seals which can adversely impact product package integrity/product sterility.

LabPro V3.01 Panel Update-01 Siemens Healthcare Diagnostics Inc. 2009-12-21 2009-11-30 51937 Type III 9800-3771 Software Version 3.01 Siemens Healthcare Diagnostics received customer complaints regarding QC isolates when tested on the walkaway instrument. Following the installation of LabPro 3.01 panel update -01 and utilization of the panel type POS combo 33 (PC33), an issue has been confirmed for

Dade Hepzyme (B4240-10) Siemens Healthcare Diagnostics Products GMBH 2009-12-21 2009-12-02 51994 Type III B4240-10 528752

QC isolates when tested on the walkaway instrument. This issue only applies to those that have installed the LP V3.01 panel update-01 (9800-3768 compact disk). QC issue affects combo type panels. Customer complaints regarding incorrect high APTT values that may be observed on heparin and heparin-free samples treated with lot 528752 of Dade Hepzyme when using lot

IW900 Series Infant Warmer Fisher And Paykel Healthcare Ltd. 2009-12-21 2009-09-07 51309 Type III IW910, IW920, IW930, IW932, IW934, IW950, IW980, WITH SUFFIX JEU

All Infant Warmers in Canada.528752 of Dade Hepzyme with non-Siemens APTT reagents. Notifying users in Canada of updating cleaning instructions for the IW900 series infant radiant warmers. The inclusion of the recommended and non-recommended proprietary cleaning products supplements the current operating instructions and technical manual held

CyberKnife Robotic Radiosurgery System Accuray, Inc. 2009-12-21 2009-06-22 50252 Type II 28000 C202

by Canadian customers which already cautions against using solutions containing specifically named chemicals.A healthcare facility reported their end-to-end targeting accuracy was out of specification. The position of one of the robotic manipulator axes differed from the position determined by the robotic controller. Error 103 (karel e-stop detected) and error 342 (deviation in absolute position value DSE - RDC) were displayed.