Events

Recall of Philips HeartStart MRx cardiac monitor / defibrillator

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-2012-RN-00735-3
  • Event Risk Class
    Class II
  • Event Initiated Date
    2012-07-19
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-00735-3
  • 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
    Due to a corrupt data card some heartstart mrx defibrillator/monitors manufactured within these time periods may have incomplete 12-lead program files, and if so will present the following behaviour:- the device cannot analyse a 12-lead ecg report. due to this a user cannot view, print or transmit a 12-lead ecg.- a message 'cannot analyse ecg' is displayed on the mrx when an attempt to acquire a 12-lead report is made.
  • Action
    User may continue to use an affected device, however the 12 lead report will not be generated, Philips Healthcare recommends have a back up device available. Philips Healthcare will be providing a software update to permanently correct the issue.

Device

Philips HeartStart MRx cardiac monitor / defibrillator
  • Model / Serial
    Philips HeartStart MRx cardiac monitor / defibrillator, model number: M3536A with R.03.03 software and 12 Lead option (manual defibrillator)Model number: M3536A with R.03.03 software and 12 Lead option (or with the capability to install 12 lead option)Manufactured between April 17 2012 and May 8 2012Multiple serial numbersARTG number: 95661
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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