Events

Recall of Wireless Link for HeartStart MRx 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-2014-RN-00208-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2014-02-25
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00208-1
  • 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
    Wireless link may be unable to trasmit data when configured for a specific data flow. this specific condition may only occur when the wireless link is configured to operate in access point mode in data management. if this occurs, the mrx user will be informed of this inability to transmit data via visual notifications on mrx.
  • Action
    Philips will be installing a software update to correct the issue. Philips is advising MRx users that while awaiting for the software update they can continue to use the Wireless Link with the MRx. If the issue occurs the Wireless Link should be removed from service and Philips Customer Care contacted. This action has been closed-out on 12/02/2016.

Device

Wireless Link for HeartStart MRx Monitor/Defibrillator
  • Model / Serial
    Wireless Link for HeartStart MRx Monitor/Defibrillator Serial Numbers: US00100253 and US00561724ARTG Number: 95661
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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