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Showing 86241–86260 of 92420 results

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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

Maxi-Heat Dream Tower Heater – Fire Risk (2006)

The recalled model is CH920. The ceramic portable electric heaters are the oscillating tower type. They are gray and have a control panel attached to the top of the unit. "Maxi-Heat™" is printed on the control panel. The model number is printed on the ETL label on the bottom of the back side of the unit.

CPSCJan 26, 2006Nationwide

Bradley Electric Smokers – Electric Shock Hazard (2006)

The recalled electric smokers include models BTST02 (stainless steel) and BTIS1 (black) and consist of a smoke generator, a smoke tower and two power cords. The model number appears on a silver label on the back of the smoker. The products have a "Bradley Smoker" logo on the door and at the bottom, under the red light "Power Indicator." The recalled black smokers contain one of the following serial numbers: 0508000110000001 to 0508000110000354 0508000113000001 to 0508000113000294 0508000116000001 to 0508000116000354 The recalled stainless steel smokers contain one of the following serial numbers: 0508000111000001 to 0508000111000354. The serial number appears on a label on the back of each smoker.

CPSCJan 26, 2006Nationwide

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.

Children's Outerwear – Drawstring Strangulation Risk (2006)

The recalled garments are various color jackets, coats, sweatshirts and sweaters, sold in youth sizes up to size 12 with drawstrings through the hood. Many of the sweatshirts have the names of colleges and universities written on them. A tag sewn on the garment reads, "Steve & Barry's Quality Athletic Goods." The style numbers are 15178, 16105, 16168, 16230, 16231, 16257, 16509, 17197, 17285 and 18346, which is written on a collar or side label.

CPSCJan 26, 2006Nationwide

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