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Showing 18901–18920 of 22584 results

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Sunrise Medical: DeVilbiss iFill Personal Oxygen Station model number 535D.

Potential for oxygen cylinders to not fill completely

FDAAug 24, 2006Nationwide• Sunrise Medical

Philips Medical Systems North America Co. Phillips: Allura Xper FD 10/10 x-ray, angiographic system

Potential for x-ray system to freeze during an examination, and inability of table to be re-positioned.

FDAAug 24, 2006Nationwide• Philips Medical Systems North America Co. Phillips

Drew Scientific Group PLC: Bayer Advia 70 Hematology Analyzer, manufactured by Drew ...

Flags and alerts on the user interface will not automatically transfering to the LIS.

FDAAug 24, 2006FL, MA, MN +5 more• Drew Scientific Group PLC

Drew Scientific Group PLC: Drew Excell 22 Hematology Analyzer, manufactured by Drew ...

Flags and alerts on the user interface will not automatically transfering to the LIS.

FDAAug 24, 2006FL, MA, MN +5 more• Drew Scientific Group PLC

Nihon Kohden America Inc: Nihon Kohden Electric Stimulator, Model number: MS-210BK ...

When the device is subject to physical shock, such as a drop to the floor, it may output a different value from the preset value. This may result in a superficial burn on the patient if the stimulation is done for a long time.

FDAAug 23, 2006Nationwide• Nihon Kohden America Inc

Bemis Health Care, Inc: 5 Qt. Wallmount Sharps Container, Model 150, Regular Size...

The 5 Quart Wall Safes are shipped as two pieces (bottom & top) that customers are unable to assemble because of excess warp in the back wall of the container.

FDAAug 23, 2006Nationwide• Bemis Health Care, Inc

Hardy Media Inc Dba Hardy Diag: HardyCHROM 0157, Catalogue Number: G305, Lot Numbers: 061...

Performance failure; the product is failing to show pigment development for E. coli 0157.

FDAAug 21, 2006Nationwide• Hardy Media Inc Dba Hardy Diag

Hill-Rom, Inc.: Hill-Rom Affinity Three Birthing Bed, Model P3700.

The cable on the auxiliary outlet may become pinched, which may result in an electrical short with melting of the plastic transformer and the emission of smoke.

FDAAug 18, 2006Nationwide• Hill-Rom, Inc.

First Aid Only Inc: First Aid kits, First Aid Only brand, containing various ...

Kits contain acetaminophen tablets that were recalled due to being contaminated with mold.

FDAAug 17, 2006Nationwide• First Aid Only Inc

First Aid Only Inc: First Aid kits, Pharmacist''s Choice, containing acetamin...

Kits contain acetaminophen tablets that were recalled due to being contaminated with mold.

FDAAug 17, 2006Nationwide• First Aid Only Inc

bioMerieux, Inc.: bioMerieux BacT/ALERT SN Anaerobic Culture Bottle-REF 25...

Recovery Compromised-during manufacturing ambient air (including oxygen) was inadvertently introduced into the culture bottles, changing their reduction/oxidation potential thus leading to a compromised recovery of some obligate anaerobes and longer detection times.

FDAAug 17, 2006Nationwide• bioMerieux, Inc.

Datex Ohmeda, Inc: GE Healthcare Innova 3100 IQ Digital Fluoroscopic Imaging...

User was unable to hear the Innova 2100-IQ 5-minute fluoroscopy warning signal from the Table Control TSSC interface. Inability of the user to hear the audible signal indicating the completion of any preset exposure time may lead to incorrect overall dose management, resulting in unnecessary exposure and can be a contributing factor for skin injury. The alarm can be heard in the control room.

FDAAug 17, 2006AL, AZ, AR +36 more• Datex Ohmeda, Inc

Datex Ohmeda, Inc: GE Healthcare Innova 4100 IQ Digital Fluoroscopic Imaging...

User was unable to hear the Innova 2100-IQ 5-minute fluoroscopy warning signal from the Table Control TSSC interface. Inability of the user to hear the audible signal indicating the completion of any preset exposure time may lead to incorrect overall dose management, resulting in unnecessary exposure and can be a contributing factor for skin injury. The alarm can be heard in the control room.

FDAAug 17, 2006AL, AZ, AR +36 more• Datex Ohmeda, Inc

EMD Chemicals Inc: Anaerotest;Microbiology , 50 test strips 1.15112 Store dr...

Lot # OC553145 of Anaerotest failed to remain in specification. QC indicator shows an anaerobic environment even if oxygen is present

FDAAug 17, 2006Nationwide• EMD Chemicals Inc

First Aid Only Inc: First Aid Kit, Nexcare brand, all purpose first aid kit c...

Kits contain acetaminophen tablets that were recalled due to being contaminated with mold.

FDAAug 17, 2006Nationwide• First Aid Only Inc

EMD Chemicals Inc: Anaerotest for microbiology Specification: Performance Te...

Lot # OC553145 of Anaerotest failed to remain in specification. QC indicator shows an anaerobic environment even if oxygen is present.

FDAAug 17, 2006Nationwide• EMD Chemicals Inc

Datex Ohmeda, Inc: GE Healthcare Innova 2100 IQ Digital Fluoroscopic Imaging...

User was unable to hear the Innova 2100-IQ 5-minute fluoroscopy warning signal from the Table Control TSSC interface. Inability of the user to hear the audible signal indicating the completion of any preset exposure time may lead to incorrect overall dose management, resulting in unnecessary exposure and can be a contributing factor for skin injury. The alarm can be heard in the control room.

FDAAug 17, 2006AL, AZ, AR +36 more• Datex Ohmeda, Inc

Becton Dickinson & Co.: BD BBL Staphyloslide Latex Test Kit, Catalog # 240952 (1...

False Negative Staphylococcus aureus results which could prevent infected patients from receiving antimicrobial treatment; due to the failure of the Positive Control to react within 20 seconds. The failure is due to reduced reactivity of the latex component.

FDAAug 17, 2006Nationwide• Becton Dickinson & Co.

GE OEC Medical Systems, Inc: GE OEC 9800 Fluoro C-Arm X-ray System, GE OEC Medical Sys...

X-ray systems could provide output which exceeds the 20 R/minute limit.

FDAAug 16, 2006Nationwide• GE OEC Medical Systems, Inc

International Medsurg Connection, Inc.: Allegiance Esmark 4' x 108' Bandage, Latex Free, Sterile;...

The bandages labeled as sterile had not been sterilized prior to distribution.

FDAAug 16, 2006Nationwide• International Medsurg Connection, Inc.

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