Philips HeartStart FR2+ Automated External Defibrillator (AED) Recall

A recall has been issued for about 5,400 Philips HeartStart FR2+ Automated External Defibrillators (AEDs), as a defective memory chip in some of the emergency devices could cause them to fail to deliver a life-saving shock when needed.

The automated external defibrillator (AED) recall was announced by Philips on September 28, and posted on the FDA website this week. The defective devices were distributed worldwide for use by emergency responders to help treat sudden cardiac arrest.

Philips has received a number of reports that the memory chips in AEDs were failing during battery insertion tests and routine self tests conducted by the device. However, Philips indicates that there are no known incidents of the devices failing during emergency use, and no injuries have been reported.

The AEDs are designed to analyze a patient’s heartbeat and recognize whether a defibrillation shock is needed. The device then tells the emergency responder when to administer the shocks. The devices are used in hospitals, and by firefighters, paramedics and other emergency service providers.

The defective memory chip could render the AED inoperable and unable to give defibrillation shocks when needed.

The recall affects HeartStart FR2+ AEDs with the model numbers M3860A and M3861A distributed by Philips, and units with model numbers M3840A and M3841A distributed by Laerdal Medical. The devices were manufactured from May 2007 through January 2008.

Philips instructs users to return the device for a replacement at no charge. The company says it is sending letters to all known customers, but anyone who purchased one of the recalled products who does not receive a letter should go to the website and fill out an exchange form. Customers are being offered either a reconditioned and tested FR2+ AED or a newer model.