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Showing 22441–22460 of 22623 results

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Sanarus Medical Inc: Sanarus brand Centrica Rotational Core Biopsy medical dev...

Recent 'pre-tests' show that Argon gas has the potential to escape from the device during a biopsy procedure.

FDAMay 13, 2003IL, MD, OH +3 more• Sanarus Medical Inc

Abbott Laboratories HPD/ADD: T-U-R Y-Set Non-Vented Set for Transurethral Resection Pr...

The irrigation set was mislabeled with the wrong delivery rate of 8 drops/mL when it actually has a delivery rate of 11 drops/mL

FDAMay 13, 2003LA• Abbott Laboratories HPD/ADD

Misys Healthcare Systems: Misys Laboratory System, version 5.3

Two clients reported Quality Assurance dates could not be entered after 5/19/03.

FDAMay 13, 2003Nationwide• Misys Healthcare Systems

Abbott Laboratories HPD/ADD: Abbott Latex-Free Primary I.V. Plumset Convertible Pin, 9...

The I.V. administration set incorrectly lists the priming volume from the cassette inlet to distal male adapter as 13.5 mL instead of 11.3 mL

FDAMay 13, 2003FL• Abbott Laboratories HPD/ADD

Abbott Laboratories HPD/ADD: LifeShield Latex-Free 150 mL Burette Set, Nonvented, 117 ...

IV Burette administration sets are mislabeled as having pre-pierced injection sites, when the injection sites are not pre-pierced.

FDAMay 13, 2003Nationwide• Abbott Laboratories HPD/ADD

GE OEC Medical Systems, Inc: Uroview 2600 Uroview System

Uncommanded motion of the urological table is possible should the hand control assembly be exposed to liquids.

FDAMay 12, 2003Nationwide• GE OEC Medical Systems, Inc

Fujifilm Medical System USA, Inc.: Synapse Version 2.2.1 and 2.3.1 software

Synapse Version 2.2.1 and 2.3.1 Software [Free-Hand Region] may lead to incorrect density calculations during CT scan

FDAMay 12, 2003Nationwide• Fujifilm Medical System USA, Inc.

GE OEC Medical Systems, Inc: Uroview 2500 X-ray System

Uncommanded motion of the urological table is possible should the hand control assembly be exposed to liquids.

FDAMay 12, 2003Nationwide• GE OEC Medical Systems, Inc

Venetec Intl Inc: StatLock Tandem Microbore Catheter Extension Set with pre...

Set tubing disconnected from the male luer lock during use on patients. Misassembled.

FDAMay 12, 2003CT, IN, PA +1 more• Venetec Intl Inc

GE OEC Medical Systems, Inc: Uroview 2000 X-ray System

Uncommanded motion of the urological table is possible should the hand control assembly be exposed to liquids.

FDAMay 12, 2003Nationwide• GE OEC Medical Systems, Inc

Implant Innovations, Inc.: Product is a drill used in dental surgery labeled in part...

Some 8mm OsseoFix drills included in the kit may be incorrectly laser marked as 4mm OsseoFix drills.

FDAMay 9, 2003Nationwide• Implant Innovations, Inc.

Implant Innovations, Inc.: Products are surgical drills packaged separately or inclu...

Some 8mm OsseoFix drills may be incorrectly laser marked as 4mm OsseoFix drills.

FDAMay 9, 2003Nationwide• Implant Innovations, Inc.

Cobe Cardiovascular, Inc: Cobe Cardiovascular BCD Vanguard Cardioplegia Delivery Sy...

Tubing set included in Cardioplegia Delivery System was 4:1 instead of the labeled 8:1 size.

FDAMay 9, 2003MN, NE, OK• Cobe Cardiovascular, Inc

Roche Diagnostics Corp.: Roche/Hitachi Modular Analytics P clinical chemistry anal...

Incorrect results, without a data flag, reported if one of the other reagent containers becomes depleted before the R1 reagent is depleted.

FDAMay 8, 2003Nationwide• Roche Diagnostics Corp.

Beckman Coulter Inc: ACCESS Estradiol Reagent Test System

Short volume, resulting possibility of falsely elevated results.

FDAMay 8, 2003Nationwide• Beckman Coulter Inc

Guidant Corporation ACS: MULTI-LINK Pixel Coronary Stent System Size: 2.0 x 13 mm ...

Sterility compromised.

FDAMay 7, 2003Nationwide• Guidant Corporation ACS

Ventana Medical Systems Inc: iVIEW DAB Detecion Kit. Catalog Number 760-091

Kit does not stain tissues properly.

FDAMay 7, 2003Nationwide• Ventana Medical Systems Inc

Draeger Medical, Inc.: Evita 4 Continuous Ventilator

software problems - ventilation mode changes without user input, settings change without corresponding display change, false auto-set alarm.

FDAMay 7, 2003Nationwide• Draeger Medical, Inc.

Surgical Specialties Puerto Rico, Inc. Road: 2.75 mm Slit Knife, Angled, Bevel Up. Labeled '' Stylus *...

Incorrect handle was used in the manufacture of product 52-2761

FDAMay 7, 2003Nationwide• Surgical Specialties Puerto Rico, Inc. Road

Guidant Corp-Cpi Division: Discovery Multiprogrammable Pacemaker, DDDR Model 1273

In a rare circumstance (fallback mode when high-rate atrial activity is detected), the battery gauge can over-estimate battery life.

FDAMay 6, 2003Nationwide• Guidant Corp-Cpi Division

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