Events

Recall of LIFEPAK CR Plus and LIFEPAK EXPRESS Automated External Defibrillators (AED)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Physio-Control Australia Pty 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-2013-RN-00211-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-03-08
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00211-1
  • 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 some rare situations, the charge-pak replaceable battery charger has not lasted two years because of an internal electrical failure that leads to early internal battery depletion.
  • Action
    End users are instructed to continue to monitor the AED routinely for warning indicators as stated in the instructions for use. If it is determined that the device is affected by the early battery depletion issue a permanent replacement device will be provided. This action has been closed-out on 04/04/2017.

Device

LIFEPAK CR Plus and LIFEPAK EXPRESS Automated External Defibrillators (AED)

Manufacturer

Physio-Control Australia Pty Ltd
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    DHTGA