LONDON Koninklijke Philips Electronics NV (Amsterdam, The Netherlands), a leading vendor of consumer and medical products, has announced that it is recalling approximately 5,400 HeartStart FR2+ automated external defibrillators (AEDs).
Philips said the recall has been issued because of the possibility of a memory chip failure that could leave the device unable to operate. Philips did not indicate the type of memory chip concerned or the nature of the fault.
The recall affects models M3860A and M3861A, distributed by Philips, and models M3840A and M3841A, distributed by Laerdal Medical, manufactured between May 2007 and January, 2008, Philips said.
The HeartStart FR2+ defibrillators are used by trained responders and designated response teams to help treat sudden cardiac arrest. The defibrillators are intended to monitor for arrhythmic heart conditions and can apply electrical therapy which stops the arrhythmia, allowing the heart to re-establish an effective rhythm.
Philips said it has received reports of a memory chip failure in a small number of FR2+ units manufactured in 2007 and early 2008. These reported failures were detected during self-test routines and not in emergency use, Philips said. Philips said it has received no reports of injury associated with this chip failure.
Philips said it contacting customers to arrange for the return and replacement of all the recalled AEDs and has set up a page on the Philips Web site with a serial number look-up tool to allow customers to find out if their FR2+ is part of this recall. The page is www.philips.com/FR2PlusAction.
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