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Showing 22141–22160 of 22623 results

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Misys Healthcare Systems: Calculator/ Data Processing Module for Clinical Use.

Software Defect. When orders are modified before the Roche Cobas Integra query for a specimen, the sample ID locks.

FDASep 25, 2003Nationwide• Misys Healthcare Systems

Biotronik Inc: Belos VR Implantable Cardioverter Defibrillator (ICD) wit...

Potential for early depletion of Implantable Cardioverter Defibrillator battery.

FDASep 24, 2003Nationwide• Biotronik Inc

Biotronik Inc: Belos DR-T Implantable Cardioverter Defibrillator

Potential extended charge time anomalies.

FDASep 24, 2003Nationwide• Biotronik Inc

Biotronik Inc: Belos VR-T Implantable Cardioverter Defibrillator (ICD) w...

Potential for early depletion of Implantable Cardioverter Defibrillator battery.

FDASep 24, 2003Nationwide• Biotronik Inc

Concentric Medical Inc: Concentric brand Concentric Retriever X5 Percutaneous Cat...

The device has the potential for tip breakage during use.

FDASep 24, 2003CA, GA, IN +5 more• Concentric Medical Inc

Biotronik Inc: Belos VR Implantable Cardioverter Defibrillator

Potential extended charge time anomalies.

FDASep 24, 2003Nationwide• Biotronik Inc

Biotronik Inc: Belos VR-T Implantable Cardioverter Defibrillator

Potential extended charge time anomalies.

FDASep 24, 2003Nationwide• Biotronik Inc

Sandhill Scientific, Inc: ComforTEC Plus Impedance Probe, a part of the Insight S98...

Pouch containing pediatric probes was labeled as containing adult probes.

FDASep 24, 2003CO, MT, TX• Sandhill Scientific, Inc

Biotronik Inc: Belos DR Implantable Cardioverter Defibrillator

Potential extended charge time anomalies.

FDASep 24, 2003Nationwide• Biotronik Inc

Microaire Surgical Instruments: Pin Driver Coupler, component of MicroAire Drill\Reamer M...

Wiring pin locking mechanism defective, potential to come apart in surgical site.

FDASep 23, 2003Nationwide• Microaire Surgical Instruments

Bard Access Systems, Inc: Bard -Winged Infusion Set with Injection Site. Sterile, ...

Sterility of product is compromised by open seals in packaging.

FDASep 23, 2003Nationwide• Bard Access Systems, Inc

Microaire Surgical Instruments: Wire Driver Coupler, Model 7100-045, a component of Micro...

Wiring pin locking mechanism defective, potential to come apart in surgical site.

FDASep 23, 2003Nationwide• Microaire Surgical Instruments

Meridian Bioscience Inc: Premier Toxins A & B, Diagnostic Test Kits, Catalog No. 6...

The kits were packaged with incorrect dispensing pipettes.

FDASep 23, 2003Nationwide• Meridian Bioscience Inc

Vasca, Inc.: LifeSite Hemodialysis Cannula Exchange Kit Part Number: L...

Outer kit mislabeled with an extended expiration date

FDASep 22, 2003AR, CA, FL +10 more• Vasca, Inc.

Nova Biomedical Corporation: Stat Profile Ultra Magnesium Sensor (In-vitro Diagnostic ...

Degradation of the magnesium sensor could result in low ionozed magnesium patient samples

FDASep 22, 2003GA, VA• Nova Biomedical Corporation

Nova Biomedical Corporation: Stat Profile Critical Care Expres Ionized Magnesium Senso...

Degradation of the magnesium sensor could result in low ionozed magnesium patient samples

FDASep 22, 2003GA, VA• Nova Biomedical Corporation

Plus Orthopedics: Hip Stem, Sterile Pkg. The implant consists of 2 metal co...

Design Change

FDASep 19, 2003AZ, CA, CO +1 more• Plus Orthopedics

Abbott Laboratories HPD/ADD/GPRD: IMx Tacrolimus II Calibrators, list 3C10-10; the pack con...

Invalid test results are being generated due to calibration errors when using calibrator lots 94165M100 and 94164M100.

FDASep 19, 2003Nationwide• Abbott Laboratories HPD/ADD/GPRD

Qualigen Inc: Device to determine quantitative total testosterone in hu...

Kits may produce results that are falsely elevated.

FDASep 19, 2003Nationwide• Qualigen Inc

Rultract Inc: Rultract Surgical Retractor, 4100 Series, all system conf...

Component spring or nut may loosen, detach, and fall into chest of patient during surgical procedure.

FDASep 18, 2003Nationwide• Rultract Inc

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