Safety Notice for HeartStart MRx/MRxE, Philips
2009.05.19
Product group Medical electronics / Electromedical devices
Reference 01572/09
Philips Medizinsysteme Böblingen has issued a Field Safety Notice concerning a corrective action of the HeartStart MRx/MRxE Defibrillator/Monitor M3535A / M3536A/ M3536J. The therapy switch in devices manufactured from March 2006 to March 2009 may fail causing the device to either spontaneously turn on or to fail to respond to user initiated turn-on. As a result, the device may be rendered unusable for monitoring and therapy. The therapy switches on affected units will be replaced.
Safety Notice for HeartStart MRx/MRxE, Philips , Download_VeroeffentlichtAm_EN