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Showing 68121–68140 of 68218 results

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Philips Medical Systems (Cleveland) Inc: Philips MX8000 Dual v. EXP CT Scanner, utilizing V2.0 sof...

Patient images may be incorrectly stored in the archive directory of a different patient.

FDAApr 2, 2003Nationwide• Philips Medical Systems (Cleveland) Inc

Tosoh Bioscience, Inc.: TOSOH brand AIA-600 II Enzyme Immunoassay Analyzer; Softw...

A software upgrade was released by the firm for its AIA-600 II analyzers, in that washing deficiencies caused by the analyzer were corrected.

FDAApr 2, 2003IN• Tosoh Bioscience, Inc.

Misys Healthcare Systems: Misys Commercial Laboratory version 2.x thru 3.4.1

Urgent care STAT reports are not printing in a timely fashion.

Moderate

FDAApr 1, 2003Nationwide• Misys Healthcare Systems

Vail Products Inc: Vail Enclosed Bed System, model 1000

Patients may become entrapped between the bottom side rail and mattress.

FDAApr 1, 2003Nationwide• Vail Products Inc

Beckman Coulter Inc: Synchron Liquid Comprehensive Chemistry Control Serum. ...

The quality control samples for Vancomycin would not recover correctly when compared to the S.I. unit values listed in the incorrectly printed product insert. The incorrectly printed values were higher than they should be by a factor of 3 (three).

FDAApr 1, 2003Nationwide• Beckman Coulter Inc

Abbott Laboratories: Gemstar 7 Therapy I.V. Infusion Pump, List#: 13000-04; 2....

Products contain software deficiencies which could allow over infusion thereby administering excess medication.

FDAApr 1, 2003Nationwide• Abbott Laboratories

Abbott Laboratories: Gemstar 6 Therapy I.V. Infusion Pump, List #: 13100-04; 2...

Products contain software deficiencies which could allow over infusion thereby administering excess medication.

FDAApr 1, 2003Nationwide• Abbott Laboratories

Abbott Laboratories: Gemstar Therapy Pain Management I. V. Infusion Pump, List...

Products contain software deficiencies which could allow over infusion thereby administering excess medication.

FDAApr 1, 2003Nationwide• Abbott Laboratories

Misys Healthcare Systems: Misys Laboratory System version 5.3

Software anomally, One client reported patient tests and results are deleted when duplicate orders are placed.

FDAApr 1, 2003MI, NY, OH• Misys Healthcare Systems

Siemans Medial Solutions USA, Inc: Acuson Cypress Echocardiography System. Imaging System

software problem - loss of data

FDAApr 1, 2003Nationwide• Siemans Medial Solutions USA, Inc

Cryolife Inc: CryoValve Heart Valve

CryoLife initiated a retrospective review per FDA request, to insure that current regulatory guidelines for donor blood testing have been met for certain donors.

FDAApr 1, 2003Nationwide• Cryolife Inc

Guidant Corporation ACS: Guidant Multi-Link Vision Coronary Stent System Catalog ...

Complaints that the stents are being dislodged from the delivery system.

FDAApr 1, 2003Nationwide• Guidant Corporation ACS

Abbott Laboratories HPD/ADD: Architect Progesterone Reagent Kit; list 6C26-27 (100 tes...

Lot gives lower specimen results compared to results generated with other lots.

FDAMar 31, 2003Nationwide• Abbott Laboratories HPD/ADD

Gish Biomedical Inc: Vision Hollow Fiber Oxygenator

Two reports of leakage.

FDAMar 31, 2003Nationwide• Gish Biomedical Inc

Siemens Medical Solutions USA, Inc.: Acuson Diagnostic Ultrasound System Transducer; Model Num...

The product has a software condition in that the surface temperature of the transducer may reach above the thermal limit.

FDAMar 31, 2003Nationwide• Siemens Medical Solutions USA, Inc.

Abbott Laboratories Diagnostic Div: Aeroset Direct HDL Reagent, LN 7D67-01

Degredation prior to expiry date.

FDAMar 28, 2003Nationwide• Abbott Laboratories Diagnostic Div

Beckman Coulter Inc: COULTER PrepPlus and PrepPlus 2, Pipetting and Diluting s...

Software problem may cause the instrument to skip the probe-wash step before processing different reagents.

FDAMar 28, 2003Nationwide• Beckman Coulter Inc

Ferno-Washington Inc: PROFlex Transporter, Model numbers 35PST. The catalog nu...

The firm received complaints of the stretchers folding. A fold is when the stretcher lowers on its own to either the next position, or any of the other seven postions of the stretcher.

FDAMar 28, 2003Nationwide• Ferno-Washington Inc

Binding Site Inc The: Bindazyme, Human AntiCardiolipin IgM Enzyme Immunoassay ...

Risk of false positives.

FDAMar 27, 2003Nationwide• Binding Site Inc The

Misys Healthcare Systems: Misys Laboratory System versions 5.23 and 5.3

Software anomaly.

FDAMar 27, 2003Nationwide• Misys Healthcare Systems

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