Philips announced that it will voluntarily recall approximately 5,400 HeartStart FR2+ automated external defibrillators (AEDs), due to the possibility of a memory chip failure that may render the device inoperable.
The company has received reports of a memory chip failure in a small number of units, detected during routine self tests, not during emergency use. Failure of this chip could render the AED inoperable and prevent it from delivering therapy when indicated.
Philips has received no reports of injury associated with this chip failure.
Only models M3860A and M3861A, distributed by Philips, and models M3840A and M3841A, distributed by Laerdal Medical, manufactured between May, 2007 and January, 2008 are included in the recall.
For more information, view the FDA alert or visit Philips’ recall Web site.
