Philips issued a voluntary recall of about 5,400 of its HeartStart FR2+ automated external defibrillators after discovering a microchip failure that “may render the device inoperable.”
The Dutch conglomerate said no adverse events have been reported in connection with the recall.
It affects only a few HeartStart FR2+ models made between May 2007 and Jan. 2008. The potential problem was detected via routine self-diagnostic tests, not during emergency use, the company said.
Philips is contacting the fire departments, emergency medical services, hospitals and other organizations the device has been sold to worldwide. The company set up a website where customers can look up the serial numbers of their FR2+ devices; for more information, call (800) 263-3342.
Adverse events experienced during the use of this product can be reported to the Food & Drug Administration’s MedWatch Program:
- (800) FDA-1088 (phone)
- (800) FDA-0178 (FAX)
- MedWatch HF-2 FDA
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