Database updated: 27 October 2026

Safety Information

Medsafe Online Recall Database

Detail of Recall

Type of Product:Device
Medsafe Reference:16283
Brand Name:Philips HeartStart MRx Monitor/Defibrillator
Model:Models: M3535A, M3536A, M3536J, M3536MC
Affected:
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
Brand Name:Philips Heartstart MRx Monitor/Defib
Model:Models: M3535A, M3536A, M3536J, M3536MC
Affected:
Software version:
Recalling Organisation:Laerdal (New Zealand) Ltd
79 Apollo Drive
Rosedale
Auckland 0632
Contact Information:0800 251 400
Manufacturer:Philips Medical Systems
Issue:A component of the MRx Processor Board may be susceptible to damage from electrostatic discharge (ESD). Damage to these components can disrupt ECG and SpO2 functionality leading to an inability to perform:
" Demand mode pacing
" 12 lead ECG acquisition and analysis
" ECG monitoring via leads
" Pulse oximetry (SpO2)
The presence of this condition will be displayed on the Ready For Use (RFU) indicator as a solid Red X with periodic audio chirp.
Defibrillation, fixed mode pacing, ECG monitoring via pads/paddles, and other monitoring functions are not impacted by this issue.
Recall action type:Correction
Recall action:Product to be modified
Level of recall:Hospital/Pharmacy/Laboratory
Date Commenced:24/2/2014
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