Events

Recall of Aerius/Aerial and Aerius/Aerial Active Wheelchair Cushion

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Otto Bock 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-2014-RN-00145-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2014-02-10
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00145-1
  • 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
    During internal routine testing, otto bock has discovered there is a small risk of flammability to the cushion after it has been washed in a washing machine at high temperatures on numerous occasion.
  • Action
    Otto Bock is requesting all end users and distributors to return all units of the wheelchair cushion.

Device

Aerius/Aerial and Aerius/Aerial Active Wheelchair Cushion

Manufacturer

Otto Bock Australia Pty Ltd