SEATTLE (AP) — Philips Healthcare said Saturday it is recalling about 5,400 automated external defibrillators after receiving reports of a memory chip failure in a small number of some models that could make them inoperable.
The defibrillators are used by emergency responders to help treat sudden cardiac arrest, and the company said it is contacting customers to arrange for the devices to be replaced.
The Seatle-based company said it has received no reports of injury associated with the chip failure.
Philips said only certain HeartStart FR2+ defibrillators are included in the voluntary recall. Those included are models M3860A and M3861A distributed by Philips and models M3840A and M3841A distributed by Laerdal Medical manufactured between May 2007 and January 2008.
The devices automatically analyze the heart rhythm and determines whether a defibrillation shock is needed. If a shockable rhythm is detected, the device instructs the responder to deliver defibrillation therapy.
The reported memory chip failures were detected during routine self tests, not during emergency use of the device, Philips said.
The devices involved have been distributed around the world to fire departments, emergency medical services units, hospitals and other organizations, the company said.
It said customers who have questions or problems with the devices can call its customer service operation at 1-800-263-3342.
Philips said it has advised the U.S. Food & Drug Administration about its recall, and said any problems with use of the devices should be reported to the FDA’s MedWatch Program.
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Philips said the MedWatch phone number is (800) FDA-1088; MedWatch Web site.
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