Events

Recall of A-dec 311 Chair and A-dec 361 Support Centre

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by A-DEC Australia.

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-00380-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-05-07
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00380-1
  • 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
    The strength of some screws (or "fasteners") may have been compromised due to a plating process issue. under certain circumstances, the fasteners can become brittle, which might lead to a chair and/or delivery system instability.
  • Action
    The sponsor is advising their customers that the dealer will be replacing the fasteners with screws unaffected by hydrogen embrittlement.

Device

A-dec 311 Chair and A-dec 361 Support Centre
  • Model / Serial
    A-dec 311 Chair and A-dec 361 Support CentreA-dec 311 ChairARTG Number: 118326A-dec 361 Support CentreARTG Number: 118333 Multiple Serial Numbers (see attached)
  • Manufacturer
    A-DEC Australia

Manufacturer

A-DEC Australia
  • Source
    DHTGA