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Showing 17981–18000 of 22584 results

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GE OEC Medical Systems, Inc: GE OEC 9800 Fluoroscopic X-ray System, GE Healthcare, Sal...

X-ray systems were not configured to display Air Kerma Rate and Cumulative Air Kerma.

FDAJun 12, 2007CO, FL, GA +4 more• GE OEC Medical Systems, Inc

GE OEC Medical Systems, Inc: GE OEC 2800 mobile Fluoroscopic X-ray System, GE Healthca...

X-ray systems were not configured to display Air Kerma Rate and Cumulative Air Kerma.

FDAJun 12, 2007CO, FL, GA +4 more• GE OEC Medical Systems, Inc

GE OEC Medical Systems, Inc: GE OEC 8800 Fluoroscopic X-ray System, GE Healthcare, Sal...

X-ray systems were not configured to display Air Kerma Rate and Cumulative Air Kerma.

FDAJun 12, 2007CO, FL, GA +4 more• GE OEC Medical Systems, Inc

Cook Urological, Inc.: Cook PTFE Wire Guide with 3 cm flexible tip, to establish...

Lack of assurance of sterility, in that the product is labeled as sterile but the package may not have been sealed.

FDAJun 12, 2007Nationwide• Cook Urological, Inc.

GE OEC Medical Systems, Inc: GE OEC 6800 Fluoroscopic X-ray System, GE Healthcare, Sal...

X-ray systems were not configured to display Air Kerma Rate and Cumulative Air Kerma.

FDAJun 12, 2007CO, FL, GA +4 more• GE OEC Medical Systems, Inc

Biomet, Inc.: Vortech Graft Preparation System, sterile, single use, di...

The syringe assembly has an obstruction in the tube that prevents the plunger from being depressed.

FDAJun 11, 2007Nationwide• Biomet, Inc.

Biomet, Inc.: Graft Preparation System, sterile, single use, disposable...

The syringe assembly has an obstruction in the tube that prevents the plunger from being depressed.

FDAJun 11, 2007Nationwide• Biomet, Inc.

Philips Medical Systems: Philips Medical HeartStartXL Defibrillator/Monitor Model ...

The ECG signal may become unusable to assess patient condition and need for therapy.

FDAJun 11, 2007Nationwide• Philips Medical Systems

Thoratec Corp: Thoratec TLC-II Portable VAD Driver. Component (pneumati...

Component Failure; Device Failure without warning; due to premature wear-out of the compressor motor, VAD support for the patient's circulatory system may fail without warning.

FDAJun 8, 2007AL, AZ, AR +25 more• Thoratec Corp

Bausch & Lomb Inc: Bausch & Lomb Zyoptix XP Epi Separator, packaged 1 per st...

Reports have been received of stromal incursions after use of the product.

FDAJun 8, 2007IN, MD, MN +2 more• Bausch & Lomb Inc

Oasis Medical Inc: Premier Edge MVR 19g Microsurgical Knife, Item PE-3519

This voluntary recall has been initiated due to the product puncturing the packing during rough handling. Once the packaging is damaged, the product is no longer sterile as labeled.

FDAJun 8, 2007Nationwide• Oasis Medical Inc

Oasis Medical Inc: Eyemaxx MVR 20g Microsurgical Knife, Item #MX3020

This voluntary recall has been initiated due to the product puncturing the packing during rough handling. Once the packaging is damaged, the product is no longer sterile as labeled.

FDAJun 8, 2007Nationwide• Oasis Medical Inc

Bausch & Lomb Inc: Zyoptix XP Epi Head, packaged 1 per container, Cat. #ZXP3...

Reports have been received of stromal incursions after use of the product.

FDAJun 8, 2007IN, MD, MN +2 more• Bausch & Lomb Inc

Oasis Medical Inc: Premier Edge MVR 20g Microsurgical Knife, Item PE-3520

This voluntary recall has been initiated due to the product puncturing the packing during rough handling. Once the packaging is damaged, the product is no longer sterile as labeled.

FDAJun 8, 2007Nationwide• Oasis Medical Inc

Siemens Medical Solutions Diagnostics: ADVIA Centaur TnI-Ultra Assay, Troponin Immunoassay, 500 ...

Incorrect results: Falsely elevated Troponin values have been reported which are inconsistent with the patient's clinical picture and test negative by other Troponin assays.

FDAJun 7, 2007Nationwide• Siemens Medical Solutions Diagnostics

Bayer Healthcare LLC: Ascensia Contour Blood Glucose Monitoring System ( Bayer ...

Incorrect Unit of Measure displayed : The meters report results in the wrong unit of measurement for Canadian users.

FDAJun 6, 2007Nationwide• Bayer Healthcare LLC

Wallach Surgical Devices, Inc.: Wallach Cryotip T-00337 Anorectal Tip used with the Cryos...

The tip may separate from the probe.

FDAJun 6, 2007Nationwide• Wallach Surgical Devices, Inc.

Unknown Manufacturer: Nonabsorbable Polypropylene Synthetic Suture-Deklene, DEK...

Suture Diameter/Strength specification failure: The products may not meet their final specifications for suture diameter and/or strength which could lead to premature breakage.

FDAJun 6, 2007CO, FL, IL +3 more

Unknown Manufacturer: Various Types and Sizes of Polyethylene Synthetic Nonabso...

Suture Diameter/Strength specification failure: The products may not meet their final specifications for suture diameter and/or strength which could lead to premature breakage.

FDAJun 6, 2007CO, FL, IL +3 more

Unknown Manufacturer: Suture Diameter/Strength specification failure: Various P...

The products may not meet their final specifications for suture diameter and/or strength which could lead to premature breakage.

FDAJun 6, 2007CO, FL, IL +3 more

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