Events

Recall of Post Fuse Assembly with Power Wheelchairs (electronic wheelchair)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Invacare 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-2012-RN-00706-3
  • Event Risk Class
    Class II
  • Event Initiated Date
    2012-08-13
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-00706-3
  • 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
    Post fuse assemblies on certain models of power wheelchairs could potentially be defective in a manner that would result in the fuse not operating as intended (blowing) in the event of future damage or faults within the main wiring harness.
  • Action
    Distributors to rework affected chairs with the retrofit kits provided by the Sponsor.

Device

Post Fuse Assembly with Power Wheelchairs (electronic wheelchair)
  • Model / Serial
    Post Fuse Assembly with Power Wheelchairs (electronic wheelchair)Multiple Model Numbers.(Distributed between 11/10/2010 and 21/10/2010)ARTG 160385
  • Manufacturer
    Invacare Australia Pty Ltd

Manufacturer

Invacare Australia Pty Ltd