Events

Recall of Philips HeartStart FR3

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-00267-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-03-04
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00267-1
  • 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
    In a limited number of fr3 aeds, the printed circuit board (pcb), which contains the circuitry that supplies energy to the device, could become separated from the electrical contact points that hold the board in place. in the event that pcb becomes separated from the electrical contact points, the aed may not be ready to deliver a shock in the event of an emergency.
  • Action
    Philips is advising users to continue to use the AED if there are no alternatives available. Customer who have the affected device will be supplied with a replacement AED from Philips. This action has been closed-out on 12/02/2016.

Device

Philips HeartStart FR3

Manufacturer

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