Urgent Safety Notice for the HeartStart MRx Monitor/Defibrillators, Philips Healthcare
2014.03.31
Product group Medical electronics / Electromedical devices - electrotherapy
Reference 01120/14
Philips Healthcare has issued a Field Safety Notice concerning a corrective action of the HeartStart MRx Monitor/Defibrillators M3535A, M3536A, M3536J and M3536MC. A component of the processor board may be damaged from electrostatic discharge so that the HeartStart MRx could be unable to perform the Demand mode pacing, the 12 lead ECG acquisition and analysis, the ECG monitoring via leads and the pulse oximetry (SpO2). The processor board of the affected devices will be replaced.