FDA warns of Class 1 AED recall due to malfunction
The FDA has notified healthcare professionals and medical care organizations of the Class 1 recall of the listed 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 agency added that the unit’s self test may not detect the failure or impending failure of the component.
The affected models include:
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 between July 1, 2011, and Dec. 30, 2011.
According to the FDA, affected customers are advised to contact the firm to arrange for delivery of shipping materials for an immediate return of their AEDs for repair. The affected devices will receive a hardware correction, and the same serial number device will be returned to the customer in most cases.
The agency added that the unit’s self test may not detect the failure or impending failure of the component.
The affected models include:
- Cardiac Science: Powerheart 9300A, 9300E, 9300P, 9390A and 9390E;
- Cardiac Science: CardioVive 92532 and 92533 ;
- Cardiac Science: CardioLife 9200G and 9231;
- GE Healthcare: Responder and Responder Pro; and
- Nihon Kohden: AEDs
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 between July 1, 2011, and Dec. 30, 2011.
According to the FDA, affected customers are advised to contact the firm to arrange for delivery of shipping materials for an immediate return of their AEDs for repair. The affected devices will receive a hardware correction, and the same serial number device will be returned to the customer in most cases.