Events

Recall of Philips HeartStart FR3, software version 2.0 (Automated external defibrillator (AED))

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-00915-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-08-18
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00915-1
  • 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
    Heartstart fr3 2.0 device software contains a defect which, in unlikely situations, may cause a unit to indicate that it is ready for use though its battery is low. an aed running affected software may not report its low battery condition until the unit is turned on, and consequently may be unable to maintain the power needed to deliver therapy in an emergency.
  • Action
    Philips is advising their customers to remove affected devices from service and to take the following action promptly: - Upgrade all affected FR3 units following the instructions in the FR3 Software Upgrade Kit provided with the customer letter. This action has been closed-out on 18/04/2017.

Device

Philips HeartStart FR3, software version 2.0 (Automated external defibrillator (AED))

Manufacturer

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