Philips Medical Systems Philips Heartstart FRx automated external defibrillator (AED), Model 861304 Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

Potential for failure of a capacitor during use which would prevent the AED from delivering effective defibrillation therapy when indicated.

Recommended Action

Per FDA guidance

The firm notified their US distributors of the recall and instructed them to contact customers and provide information how to return the product to Philips for a free replacement. Firm contacted distributors via phone and email on 11/2/09 and by letter on 11/9/09. A web site providing information related to the recall was activated on 11/3/09.