Database updated: 27 October 2026

Safety Information

Medsafe Online Recall Database

Detail of Recall

Type of Product:Device
Medsafe Reference:17845
Brand Name:Philips HeartStart MRx Monitor/Defibrillator
Model:Models: M3535A & 3536A
Affected:Serial Numbers: US00100100 to US00552845 (M3535A) & US00100902 to US00552848 (M3536A)
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
Issue:The MRx can be susceptible to one or both of the issues described below.
1. The CO2 Inlet Port associated with end-tidal carbon dioxide (EtCO2) monitoring on MRx Monitor/Defibrillators can be pushed into the MRx housing, making it inaccessible. This can occur if the user attempts to push the CO2 FilterLine fitting into the Inlet Port, instead of twisting it clockwise as described in the MRx Instructions for Use.
2. The handle can separate from the MRx housing due to breakage of mounts on the rear case.
Recall action type:Correction
Recall action:Product to be modified
Level of recall:Hospital/Pharmacy/Laboratory
Date Commenced:10/12/2014
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