Events

Recall of Heron Toilet and Bath Chair

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by R82 AU 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-2017-RN-00858-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-07-11
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00858-1
  • 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
    R82 australia has been informed about breakage of the aluminium gas spring head for the tilting mechanism on the heron. this particular part was changed to a stainless steel version as of january 2016 and replacement kits are to be provided for replacement on units that still have the aluminium version to eliminate the risk of other breakages.
  • Action
    R82 is undertaking a voluntary measure of sending out stainless steel kits to replace the aluminium units to eliminate the risk of breakages and the potential for related injury. Affected customers are asked to follow the instructions in the customer letter to obtain the new kits.

Device

Heron Toilet and Bath Chair
  • Model / Serial
    Heron Toilet and Bath Chair Article Numbers: 880505-01 and 880505-11Manufactured between 23rd October 2013 to the 16th December 2015ARTG Number: 229744
  • Manufacturer
    R82 AU Pty Ltd

Manufacturer

R82 AU Pty Ltd