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Type of Product Medical Device
TGA Recall Reference RC-2012-RN-00736-3
Product Name/Description Philips HeartStart MRx cardiac monitor / defibrillators, models:M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M1, M3536M2, M3536M3, M3536M4, M3536M5 and M3536M6 (manual defibrillator)

All units manufactured prior to June 2012

(Model / manufacture date is printed on the primary label on the back of battery bay B)

ARTG Number: 95661
Recall Action Level Hospital
Recall Action Classification Class I
Recall Action Commencement Date 19/07/2012
Responsible Entity Philips Electronics Australia Ltd
Reason/Issue When HeartStart MRx Defibrillator Monitors are used in external transport and EMS environments the mechanical/electrical connection between the pads/paddles therapy cable (including pads CPR therapy cable and external paddles cable) and the MRx therapy connection port may experience higher than expected levels of stress causing accelerated wear.
Recall Action Recall for Product Correction
Recall Action Instructions Philips is revising the Instructions for Use (IFU) to include additional requirements and instructions for ongoing inspections of these devices, informing users that the lifespan of this device is 3 years and is providing support for users needing to replace cables.
Contact Information 1800 251 400 - Philips Customer Care Centre