Philips HeartStart Defibrillators Recalled Due to Faulty Memory Chips

About 5,400 HeartStart FR2+ automated external defibrillators made by Philips have been recalled because they may carry a defective memory chip that can render the life-saving devices inoperable, the Food and Drug Administration said.

There have been reports of the memory chips in some of the defibrillators failing during routine self tests, but not while in use during emergencies, according to the FDA. There have been no reports of patient injuries or deaths associated with the defective HeartStart FR2+ defibrillators, officials said.

Only defibrillator models M3860A and M3861A, distributed by Philips, and models M3840A and M3841A, distributed by Laerdal Medical, are involved in the voluntary recall, the FDA said. All the recalled units were manufactured between May 2007 and January 2008.

The products are used worldwide by fire departments, hospitals, ambulances, and other emergency medical services to treat victims suffering from sudden cardiac arrest. The devices automatically analyze the heart rhythm and determine whether a defibrillation shock is needed. If a shockable rhythm is detected, the FR2+ instructs the responder to deliver defibrillation therapy.

Philips is contacting customers who purchased the recalled defibrillators to arrange for their return and replacement, the FDA said. The company also has set up a page on the Philips Web site — www.philips.com/FR2PlusAction — with a serial number look-up tool to allow customers to find out if their FR2+ is part of this recall, as well as instructions on what to do if it is.

Other Recent Defibrillator Recalls

In addition to the Philips FR2+ defibrillator recall, other manufacturers of the devices have recently announced their own product recalls.

In September, Physio-Control, Inc. and the Food and Drug Administration recalled certain LIFEPAK CR Plus Automated External Defibrillators, which officials said might malfunction in humid weather and improperly read heart rhythms.

No related posts.