Safety Notice for HeartStart FR2+ automated external defibrillators (AEDs), Philips
2010.08.12
Product group Medical electronics / Electromedical devices
Reference 02120/10
Philips Healthcare has issued a Field Safety Notice concerning a corrective action of the automated external defibrillators (AEDs) HeartStart FR2+. Models M3840A, M3841A M3860A and M3861A manufactured between May 2007 and May 2010 may contain a voltage detector which has a higher than expected rate of failure. Failure of this component can cause the AED battery to drain more rapidely than normal or to render the AED unusable. Affected devices will be replaced.