Events

Recall of Philips HeartStart MRx Monitor/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
    Recall
  • Event ID
    18144
  • Event Initiated Date
    2015-03-10
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • 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
    The mrx could reboot once in any operating mode if the following sequence occurs:, 1. in service mode, the status log is cleared, 2. prior to exiting service mode, the mrx generates an entry in the status log., 3. service mode is exited., , the mrx is then in a state that could trigger a reboot at an indeterminate time, potentially causing therapy to be interrupted or delayed. the mrx will restart within 8 seconds., note: if a reboot occurs during clinical use, current device settings and patient record are retained.
  • Action
    Software to be upgraded

Device

Philips HeartStart MRx Monitor/Defibrillator

Manufacturer

Philips Medical Systems (USA)
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    NZMMDSA