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Type of Product Medical Device
TGA Recall Reference RC-2013-RN-00344-1
Product Name/Description Philips HeartStart MRx Monitor/Defibrillator

Model Numbers: M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5 & M3536M6

ARTG Number: 95661
Recall Action Level Hospital
Recall Action Classification Class I
Recall Action Commencement Date 18/04/2013
Responsible Entity Philips Electronics Australia Ltd
Reason/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 Recall for Product Correction
Recall Action Instructions Philips is providing a software update to correct the issue. In the interim, Philips is providing users with work around instructions and recommends that a backup defibrillator be made available during use. This action has been closed-out on 12/02/2016.
Contact Information 1800 251 400 - Philips Customer Care Centre