Information for the automated external defibrillators HeartStart HS1 and HeartStart FRx, Philips
2009.12.21
Product group Medical electronics / Electromedical devices
Reference 04499/09
Philips Healthcare has issued a Field Safety Notice concerning a corrective action of the HeartStart HS1 (models M5066A/67A/68A) and HeartStart FRx (model 861304) automated external defibrillators (AED) manufactured in October 2009. The affected devices may contain a defective capacitor. A capacitor failure could prevent the AED from delivering effective defibrillation therapy when indicated. The affected devices will be replaced.