Special Report
Defibrillator Recall: Cardiac Science Powerheart, CardioVive, Nihon Kohden (NK) and GE Responder

Apr 28, 2010 - 11:45:43 AM

The FDA is recalling Nihon Kohden and GE Responder models of automatic and semiautomatic defibrillators due to faulty components. In November the FDA recalled Powerheart, and CardioVive external defibrillators because the models were found to have defective parts and may not work properly.

The recalled defibrillators, made by Cardiac Science Corporation, may fail to properly deliver a shock and have been found to have faulty parts that may cause them to fail at delivering that lifesaving shock. Other issues with the devices include failures in accurately reading and analyzing the heart rhythm as well as failure to recognize the pad placement during use.

Recalled defibrillators should be repaired or replaced. The FDA says the recalled defibrillators should be used unless another defibrillator is available. It says the potential benefits of using the available external defibrillators outweigh the risk of not using any of the affected external defibrillators or the risk of device failure.

For more information and an updated list of the affected models
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm191426.htm



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