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Showing 65281–65300 of 68218 results

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Roche Diagnostics Corp.: Roche brand Elecsys Troponin T; catalog number 2017644.

A false negative result may be reported.

FDAJan 31, 2006Nationwide• Roche Diagnostics Corp.

Medtronic Emergency Response Systems, Inc.: LIFEPAK EXPRESS defibrillator

One of the printed circuit board assemblies may be contaminated with solder flux which can cause a short that may render the device inoperative.

FDAJan 31, 2006Nationwide• Medtronic Emergency Response Systems, Inc.

Medtronic Emergency Response Systems, Inc.: LIFEPAK CR Plus defibrillator

One of the printed circuit board assemblies may be contaminated with solder flux which can cause a short that may render the device inoperative.

FDAJan 31, 2006Nationwide• Medtronic Emergency Response Systems, Inc.

Straumann Manufacturing Inc.: Thermoplastic templates, single tooth Catalog Number: 040...

Pilot drills may not fully extend through drill guide in template products

FDAJan 30, 2006Nationwide• Straumann Manufacturing Inc.

Straumann Manufacturing Inc.: Thermoplastic templates, free-end situation Catalog Numbe...

Pilot drills may not fully extend through drill guide in template products

FDAJan 30, 2006Nationwide• Straumann Manufacturing Inc.

Nova Biomedical Corporation: Stat Profile Critical Care (CCX) Analyzer Catalog Number...

Analyzers may fail to perform scheduled automatic two-point calibrations and Quality Control runs

FDAJan 27, 2006Nationwide• Nova Biomedical Corporation

Nova Biomedical Corporation: Stat Profile Critical Care PLUS (CCX) Analyzer Catalog ...

Analyzers may fail to perform scheduled automatic two-point calibrations and Quality Control runs

FDAJan 27, 2006Nationwide• Nova Biomedical Corporation

Covidien LP: LigaSure Atlas Laparoscopic Vessel Sealer/Divider

Sealing cycle may be interrupted during vessel ligation procedure, resulting in an incomplete seal.

FDAJan 27, 2006Nationwide• Covidien LP

Cryolife Inc: CryoValve, Pulmonary Valve & Conduit

Additional serological testing performed after distribution indicates the donor has a past Hepatitis B infection.

FDAJan 27, 2006NY• Cryolife Inc

Covidien LP: LigaSure Atlas 20 cm Open Procedure Vessel Sealer/Divider

Sealing cycle may be interrupted during vessel ligation procedure, resulting in an incomplete seal.

FDAJan 27, 2006Nationwide• Covidien LP

Nova Biomedical Corporation: CCX Operating Software , Version 4.08

Analyzers may fail to perform scheduled automatic two-point calibrations and Quality Control runs

FDAJan 27, 2006Nationwide• Nova Biomedical Corporation

Cardiac Science Corporation: Powerheart AED G3 Automated External Defibrillator Model ...

Some Powerheart AED Model 9300A may contain a suspect electronic component and there is a remote likelihood that the function of this device may be interrupted during the charge.

FDAJan 27, 2006Nationwide• Cardiac Science Corporation

Hitachi Medical Systems America Inc: Hitachi Altaire Magnetic Resonance Imaging System

Circuit Failure-There is the potential risk of the Phase Loss Detector Safety Device (PHSEN PCB) malfunctioning in the event of a power loss. The circuit may fail to turn off the system main breaker when 2 of the 3 power phases are lost.

FDAJan 27, 2006Nationwide• Hitachi Medical Systems America Inc

General Electric Med Systems LLC: Discovery ST PET/CT imaging system with gantry model numb...

The LightSpeed CT Technical Reference Manual was omitted from the document kit shipped with the PET/CT system.

FDAJan 26, 2006Nationwide• General Electric Med Systems LLC

Tosoh Bioscience Inc: TOSOH ST AIA- PACK TT3, Lot FX17440, catalog #025...

The inner foil packs of AIA-PACK ST TT3, Lot FX17440 contain an incorrect expiration date of 10/2005. The outer box is labeled with the correct expiration date of 10/2006.

FDAJan 26, 2006GA, KS, TX +1 more• Tosoh Bioscience Inc

Cook, Inc.: Cook Zilver 635 Biliary Stent - Expanding Stent, delivery...

The side of the boxes give incorrect sizes for these stents. The label front is correct.

FDAJan 26, 2006CA, PA, UT• Cook, Inc.

Alfa Wassermann, Inc: Gemcal Reference Serum (magnesium calibrator). Calibrato...

Inaccurate test results. The magnesium values for the A31/A41 Gemcal Serum calibrator gave control results that were biased approx. 20% high.

FDAJan 26, 2006Nationwide• Alfa Wassermann, Inc

QLT USA, Inc.: Atrisorb FreeFlow Bioabsorbable Guided Tissue Regeneratio...

Injectable needles were included in procedure kits instead of sterile blunt cannulas.

FDAJan 26, 2006PA• QLT USA, Inc.

RC2 Brands Inc., The First Years: The First Years Cool Animal Teether/Fish, Zebra and Dinos...

Liquid Filled Infant teething ring contaminated with Pseudomonas aeruginosa and Pseudomonas putida

FDAJan 25, 2006Nationwide• RC2 Brands Inc., The First Years

RC2 Brands Inc., The First Years: Disney Baby Soft Cool Ring Teether Style # Y1470

Liquid Filled Infant teething ring contaminated with Pseudomonas aeruginosa and Pseudomonas putida

FDAJan 25, 2006Nationwide• RC2 Brands Inc., The First Years

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