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Type of Product Medical Device
TGA Recall Reference RC-2014-RN-00236-1
Product Name/Description Philips HeartStart MRx Monitor/Defibrillator

Model numbers: M3535A, M3536A, M3536J, M3536M, M3536M5, and M3536MC

Units Affected: Serial numbers within the range US00100100 - US00550668

ARTG Number: 95661
Recall Action Level Hospital
Recall Action Classification Class I
Recall Action Commencement Date 27/02/2014
Responsible Entity Philips Electronics Australia Ltd
Reason/Issue The ECG trunk cable and connector block of the MRx could be susceptible to accelerated wear, which could result in an interrupted ECG signal. Interruption of the ECG signal can cause:
- Loss of demand mode pacing
- Inability to perform synchronized cardioversion with paddles
- Disruption of leads ECG monitoring, which could delay appropriate treatment

Defibrillation, fixed mode pacing, ECG monitoring via pads/paddles and other monitoring functions are not impacted by this issue.
Recall Action Recall for Product Correction
Recall Action Instructions Philips is initiating a hardware upgrade to the affected devices. Users can continue to use the MRx prior to receiving the hardware upgrade while remaining aware of the issues identified above. If the problem occurs refer to the HeartStart MRx Instructions For Use for troubleshooting assistance. Additional workaround instructions are provided in the customer letter.
Contact Information 1800 251 400 - Phillips Customer Care Centre