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Showing 22601–22620 of 22628 results

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Roche Diagnostics Corp.: CoaguChek Pro DM meter; catalog # 1894048 and 1893211.

High frequency signals from other medical or communications equipment will result in a variable positive bias in test results.

FDAMar 12, 2003Nationwide• Roche Diagnostics Corp.

Canon USA Inc: Rational Imaging TM Software, model Ultra 10 PACS System...

Imaging archive system software mismatches images and patient names.

FDAMar 11, 2003AR, CA, IA +2 more• Canon USA Inc

Invacare Corp: Tarsys 1st Generation Seating System - an optional access...

Fire/Burn Risk

A short circuit within the charger harness may cause heat damage to the units with potential for fire.

High

FDAMar 10, 2003Nationwide• Invacare Corp

Greiner VACUETTE North America: Vacuette, Safety Blood Collection Set with Luer Adapter

The needle portion of the Safety Blood Collection Sets, may become separated from the body of the Luer Adapter.

FDAMar 10, 2003Nationwide• Greiner VACUETTE North America

Permobile Inc.: Permobil Chairman 2K powered wheelchair

One of the wheelchair motors needed a grounding strap to ensure that the motors are at the same voltage potential as the chassis of the wheelchair.

FDAMar 7, 2003Nationwide• Permobile Inc.

Steris Corp: C1406, QLC1406, C1473, and QLC1473 Quick Connect for Olym...

The Steris device may not attach properly to retrofitted Olympus bronchoscopes, and become loose during the sterile processing cycle.

FDAMar 7, 2003Nationwide• Steris Corp

Instrumentation Laboratory Co.: GEM Premier 3000 Pak pH, pC02, pO2, Hct Sensor and Reag...

Incorrect bar code applied to cartridges could result in inaccurate pO2 value

FDAMar 7, 2003CA, FL, NY +2 more• Instrumentation Laboratory Co.

Instrumentation Laboratory Co.: GEM Premier 3000 Pak Sensor pH, pC02, pO2, Hct and Reag...

Incorrect bar code applied to cartridges could result in inaccurate pO2 value

FDAMar 7, 2003CA, FL, NY +2 more• Instrumentation Laboratory Co.

Roche Molecular Systems Inc: COBAS TaqMan analyzer, Series 96; catalog number 8080216.

A false positive result may be reported.

FDAMar 6, 2003Nationwide• Roche Molecular Systems Inc

I-Flow Corporation: Paragon Administration Set (100 ml x 0.5 ml/hr) Part Num...

Wrong component may result in over infusion of medications.

FDAMar 5, 2003MA, NY• I-Flow Corporation

Olympus America Inc. Two: Brand name: Olympus ImageManager Software, Versions 6.0 ...

Software defect; potential under certain circumstances to incorrectly identify endoscopy images that have been uploaded & saved to the network system.

FDAMar 5, 2003Nationwide• Olympus America Inc. Two

Diagnostica Stago, Inc.: STA-Compact Hemostasis System with Cap piercing capability.

With maintenance of the STA line, the cap-piercing feature may involve potential risk of needle puncture injury.

FDAMar 5, 2003Nationwide• Diagnostica Stago, Inc.

Midmark Corp: Midmark M7 UltraClave and Ritter M7 SpeedClave, Tabletop ...

The pressure relief valve may fail to open properly.

FDAMar 5, 2003AZ, CA, FL +8 more• Midmark Corp

Abbott Laboratories HPD/ADD: CA 15-3 Calibrators, list 9C08-01; the pack contains six ...

The CA 15-3 Calibrators may cause depressed values for the CA 15-3 High Control and for patient specimens.

FDAMar 4, 2003Nationwide• Abbott Laboratories HPD/ADD

I-Flow Corporation: Homepump Eclipse Infusion Pump, Disposable Elastomeric In...

Product infuses too fast at rate of 30 minutes instead of 2 hours. Component mix-up.

FDAMar 4, 2003CA, IL, MI +5 more• I-Flow Corporation

Abbott Laboratories HPD/ADD: IMx CA 15-3 Reagent Pack, list 6A75-22; this reagent pack...

The CA 15-3 Calibrators may cause depressed values for the CA 15-3 High Control and for patient specimens.

FDAMar 4, 2003Nationwide• Abbott Laboratories HPD/ADD

Cti Pet Systems Inc: ECAT Software Versions V7.1.1b, V7.2, V7.2.1, and V7.2.2 ...

Incorrect patient information is displayed in the reconstructed images of a whole body patient scan.

FDAMar 4, 2003Nationwide• Cti Pet Systems Inc

Abbott Laboratories HPD/ADD: Abbott AxSYM CA 15-3 Master Calibrator Pack, list 3B42-30...

The CA 15-3 Calibrators may cause depressed values for the CA 15-3 High Control and for patient specimens.

FDAMar 4, 2003Nationwide• Abbott Laboratories HPD/ADD

Abbott Laboratories HPD/ADD: Abbott IMx AFP Calibrators, list 2271-01; a box of 6 bott...

The IMx AFP Calibrators may cause depressed values for the IMx AFP Low Control, and cause patient results to be 20% lower than actual values

FDAMar 4, 2003Nationwide• Abbott Laboratories HPD/ADD

Mitek Worldwide: Mitek M. Kurosaka Advantage 7 X 30 mm Cannulated Fixation...

Mislabeled product: Screw length incorrectly labeled may contain a 20 mm instead of 30 mm.

FDAFeb 28, 2003CO, FL, MN +2 more• Mitek Worldwide

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