Events

Recall of Philips HeartStart MRx Monitor/Defibrillators

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Philips Electronics Australia Ltd.

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
    RC-2015-RN-00149-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2015-02-20
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00149-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • 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 will restart within 8 seconds. if a reboot occurs during clinical use, current device settings and patient record are retained.
  • Action
    A software upgrade will be provided to correct the issue. Philips is advising end users that the MRx can continue to be used prior to receiving the software update. End users are advised that if the MRx reboots during clinical use, continue to treat the patient according to your organization’s protocol, reinitiating therapy if necessary.

Device

Philips HeartStart MRx Monitor/Defibrillators
  • Model / Serial
    Philips HeartStart MRx Monitor/DefibrillatorsUnits Affected:Model - Serial numbersM3535A: US00100100 to US00578696M3536A: US00100902 to US00576650M3536J: US00209838 to US00332675M3536M: US00500002 to US00553553M3536MC: US00500001 to US00500087M3536M2: US00554176, US00554177, US00554178M3536M5: US00500001 to US00562935M3536M6: US00554358 to US00576619ARTG number: 95661
  • Product Classification
    Cardiovascular Devices
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

Philips Electronics Australia Ltd
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    DHTGA