The FDA notified healthcare professionals and medical care organizations of the Class 1 recall of Cardiac Science Powerheart, CardioVive, CardioLife; GE Responder and Responder Pro, and Nihon-Kohden Automated External Defibrillators (AEDs), which contain a component that may fail unexpectedly due to a defect. If the component were to fail during a rescue attempt, the AED may not deliver defibrillation therapy, causing serious adverse health consequences, including death. The unit’s self test may not detect the failure or impending failure of the component.
Affected Models include: Powerheart 9300A, 9300E, 9300P, 9390A, and 9390E; CardioVive 92532, 92533; CardioLife 9200G and 9231; and GE Responder and Responder Pro.
These products are used for emergency treatment of victims showing symptoms of sudden cardiac arrest who are unresponsive and not breathing. These AEDs were manufactured and distributed from July 1, 2011 through December 30, 2011.
Affected customers should immediately return their AEDs for repair. The manufacturer states the affected devices will receive a hardware correction, and the same serial number device will be returned to the customer in most cases.
See the FDA Recall