Recall of Philips MRx HeartStart Defibrillator

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Philips Medical Systems (USA).

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
  • Event ID
  • Event Initiated Date
  • Event Country
  • Event Source
  • Event Source URL
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and New Zealand.
  • Extra notes in the data
    Recalling Organisation: Philips New Zealand Commercial Limited, Level 3, 123 Carlton Gore Road, Newmarket, AUCKLAND 1023
  • Reason
    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. without routine periodic inspections and preventive action by users, wear of the connection could ultimately prevent the device from sensing that the pads/paddles therapy cable is connected. this wear also may cause the mrx to inappropriately identify the pads therapy cable, external paddles, or internal paddles.
  • Action
    Instructions for use to be updated


  • Model / Serial
    Model: models M3535A and M3536A, M3536J, M3536M, M3536MC, M3536M1, M3536M2, M3536M3, M3536M4, M3536M5, M3536M6., Affected: All units manufactured prior to June 2012
  • Manufacturer


  • Manufacturer Parent Company (2017)
  • Source