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Type of Product Medical Device
TGA Recall Reference RC-2012-RN-00738-3
Product Name/Description Philips HeartStart MRx cardiac monitor / defibrillator, model numbers: M3535A, M3536A, M3536M4, M3536M5, and M3536M6 (manual defibrillator)

Multiple affected units

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 Some HeartStart MRx monitor/defibrillators may contain compromised electronic components and present the following behaviours:
·In automatic external defibrillator (AED) mode, the MRx may have difficulty interpreting the pads ECG waveform. The MRx may incorrectly analyse the rhythm or may fail to analyse the rhythm.
· In manual defibrillation mode, if the pads/paddles ECG signal is viewed, the user may have trouble interpreting the pads/paddles waveform and determining whether or not to deliver therapy.
· When using Q-CPR Measurement and Feedback, the feedback on ventilation rate may be inaccurate.
Recall Action Recall for Product Correction
Recall Action Instructions Philips is replacing the affected component at customer facilities and is providing preventative/work around instructions.
Contact Information 1800 251 400 - Philips Customer Care Centre