Database updated: 27 October 2026

Safety Information

Medsafe Online Recall Database

Detail of Recall

Type of Product:Device
Medsafe Reference:14531
Brand Name:Philips HeartStart MRx Monitor/Defibrillator
Model:Models: M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6
Affected:Serial numbers within the range US00100100 to US00565942
Software version:
Recalling Organisation:Philips New Zealand Commercial Limited
Level 3
123 Carlton Gore Road
Newmarket
AUCKLAND 1023
Contact Information:0800 251 400
Manufacturer:Philips Medical Systems
Issue:The Philips HeartStart MRx Monitor/Defibrillator may fail to deliver defibrillation therapy in either Manual Defib or AED mode. If this occurs, the MRx may simultaneously display a "No Shock Delivered" message along with a "Shock Equip Malfunction" INOP and a Red X in the RFU indicator. In addition, the pads ECG waveform may display a non-physiologic flat line rhythm.
Recall action type:Correction
Recall action:Software to be upgraded
Level of recall:Hospital/Pharmacy/Laboratory
Date Commenced:24/4/2013
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