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Showing 18341–18360 of 22584 results

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Mizuho Orthopedic Systems Inc: OSI, 6822 IntraOp Series Tables, Operating Room tables, O...

Failure to anchor; due to a failure in the locking mechanism, the product may not anchor properly.

FDAFeb 28, 2007AL, AZ, CA +28 more• Mizuho Orthopedic Systems Inc

American Diagnostica, Inc.: American Diagnostica Inc. ACTICLOT dPT Reference 824 i...

Stability of product not assured. An increase of clotting time for both normal and abnormal plasmas

FDAFeb 28, 2007Nationwide• American Diagnostica, Inc.

Mizuho Orthopedic Systems Inc: OSI, Allegro 6800 Imaging Table (Operating), single pedes...

Failure to anchor; due to a failure in the locking mechanism, the product may not anchor properly.

FDAFeb 28, 2007AL, AZ, CA +28 more• Mizuho Orthopedic Systems Inc

Cook, Inc.: Cook ATB Advance PTA Dilatation Catheter, French size 5, ...

Mislabeled as to size: The outer label reads 7-4.0 balloon, when the balloon is actually 5-2.0.

FDAFeb 28, 2007IL, NC, SC• Cook, Inc.

Mizuho Orthopedic Systems Inc: OSI ProFx Operating Room Table 6850 , Pelvic Reconstructi...

Failure to anchor; due to a failure in the locking mechanism, the product may not anchor properly.

FDAFeb 28, 2007AL, AZ, CA +28 more• Mizuho Orthopedic Systems Inc

Roche Diagnostics Corp.: CoaguChek brand PT Test Strips; U.S. Catalog Number 31162...

The product was erroneously distributed to home users in contrast to its use for healthcare professionals only.

FDAFeb 28, 2007Nationwide• Roche Diagnostics Corp.

Siemens Medical Solutions USA, Inc: Si emans Evansi, with patient table, Part No: 44 81 586, ...

Loose Mounting Screws -- Cassette holder may become loose and result in the device dislodging and colliding with the patient.

FDAFeb 27, 2007AL, AZ, AR +28 more• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc: Si emans Simiae NT Cassette Holder Electronic Imaging Dev...

Loose Mounting Screws -- Cassette holder may become loose and result in the device dislodging and colliding with the patient.

FDAFeb 27, 2007AL, AZ, AR +28 more• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc: Si emans Simiae 3000 Cassette Holder Electronic Imaging d...

Loose Mounting Screws -- Cassette holder may become loose and result in the device dislodging and colliding with the patient.

FDAFeb 27, 2007AL, AZ, AR +28 more• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc: Si emans Simview NT Cassette Holder Electronic Imaging De...

Loose Mounting Screws -- Cassette holder may become loose and result in the device dislodging and colliding with the patient.

FDAFeb 27, 2007AL, AZ, AR +28 more• Siemens Medical Solutions USA, Inc

Bio-Logic Systems Corp: Bio-logic-Ceegraph/Sleepscan Netlink Traveler, Bio-logic ...

Battery and Battery Compartment; incorrect placement in the Netlink Traveler unit which caused a short in the wiring of the battery pack and overheating.

FDAFeb 26, 2007Nationwide• Bio-Logic Systems Corp

Steris Corp: Steris QFC1728 and QFC1729 Quick Connects used in connect...

The center insert of the adaptor #6 restrictor could become loose and/or come out of the housing and may affect the sterilization process of the attached endoscope

FDAFeb 23, 2007CA, CO, ID +12 more• Steris Corp

Beckman Coulter Inc: FP1000 Cell Preparation System Software versions 1.1 & 1....

Pressure (from recapped tubes) or vacuum (from under-filled short-draw tubes) will cause inaccurate results if not properly vented.

FDAFeb 22, 2007Nationwide• Beckman Coulter Inc

Remel, Inc.: Remel MacConkey Agar w/Sorbitol, growth medium, Catalog R...

False negative results for sorbitol fermenting bacteria such as E. Coli 0157.

FDAFeb 21, 2007Nationwide• Remel, Inc.

Alcon Refractive Horizons, Inc.: LADAR6000 Excimer Laser System

Observed 'central islands' in patients following custom myopia laser procedures using the LADAR6000 Excimer Laser. (On May 11, 2007, Alcon notified consignees that the device software programs for CustomCornea Myopia and CustomCornea Myopia with Astigmatism of the device would be deactivated)

FDAFeb 21, 2007Nationwide• Alcon Refractive Horizons, Inc.

Joerns Healthcare Inc.: Sunrise Medical-Hoyer Advance Patient Lifts (Portable and...

Unapproved Design Change (by base supplier) consisting of a reduction in the number of mast-to-base welds (from four welds to two welds).

FDAFeb 21, 2007AL, AK, AZ +42 more• Joerns Healthcare Inc.

Scanlan International Inc: SCANLAN International Mobin-Uddin Vein Holder, Sterile, D...

Incorrectly assembled by manufacturer

FDAFeb 19, 2007IN, MO• Scanlan International Inc

Abbott Laboratories: ARCHITECT Estradiol Reagent, each kit contains bottles of...

A small number of reagent kits were incorrectly configured. The affected kits contain either two bottles of conjugate or two bottles of assay diluent instead of one bottle of each.

FDAFeb 19, 2007PR• Abbott Laboratories

American Medical Systems: AMS DURA-II Distal Tips, 4 cm, Product Number 72009340, S...

Mis-labeling: The Dura-II 2 cm Universal Tips and the Dura-II 4 cm Distal Tips were incorrectly labeled with the opposite labels.

FDAFeb 19, 2007Nationwide• American Medical Systems

Gyrus ACMI Corporation: Gyrus ACMI Tripolar Ultra Cutting Forceps: 5 mm X 32 cm-R...

Product sterility may be compromised due to failure of the tray seal packaging

FDAFeb 19, 2007Nationwide• Gyrus ACMI Corporation

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