The Food and Drug Administration is reminding owners of automatic external defibrillators (AEDs) to check whether their devices are subject to a Jaunary recall. Certain AEDs contain a defective component that could cause the AED to not delvier defibrillation. Because of the seriousness of this issue the agency has classified this recall as class I, the most serious category of device safety action.
Affected devices include:
-Cardiac Science’s Powerheart (models 9300A, 9300E, 9300P,9390A, and 9390E)
-CardioVive (92532 and 92533)
-CardioLife (9200G(9200G and 9231)
-GE (Responder and Responder Pro
-Nihon-Kohden AEDs
Affected customers should contact the manufacturer immediately to arrange a return of the device. The manufacturers will install the needed hardware correction or replace the device at no charge to the customer.
