Cardiac Science Automated External Defibrillators - Powerheart, Cardiovive, NK, Responder models: Class I Recall
MedSun: Newsletter #48, May 2010

FDA MedWatch Safety Alert

This April 27, 2010 update alerts users that Nihon Kohden (NK) and GE Responder models are also affected although they were not identified in earlier communications about this recall. In addition, Cardiac Science issued a software upgrade for the devices' self tests on February 24, 2010 for the Powerheart automatic external defibrillators (Models 9390A and 9390E) and is planning on issuing a similar software upgrade for other affected devices.

Read the complete FDA MedWatch 2010 Safety, which includes links to the original Class 1 recall notice posted March 8, 2010 as well as updated recommendations.

Additional Information:

FDA MedWatch Safety Alert. Cardiac Science Automated External Defibrillators - Powerheart, Cardiovive, NK, Responder models: Class I Recall. April 27, 2010.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm205165.htm


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