Further Safety Notice for the automated external defibrillators HeartStart FR3, Philips Healthcare
2014.04.01
Product group Medical electronics / Electromedical devices - electrotherapy
Reference 01204/14
Philips Healthcare has issued a Field Safety Notice concerning a corrective action of the automated external defibrillators (AEDs) HeartStart FR3 861388 and 861389. There is the risk that units with software version 2.0 indicate that they are ready for use though their battery is low. Consequently the power needed to deliver therapy may not be maintained in an emergency. The affected devices will be corrected by a FR3 software update kit.