Events

Recall of A-dec 200 Dental Chair (examination chair)

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-2012-RN-01114-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2012-11-15
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-01114-1
  • 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
    Preliminary analysis indicates that several lots of mounting bolts were subjected to plating conditions that may have contributed to hydrogen embrittlement, which in turn could cause mounting bolt failure. it was also determined that in addition to mounting bolts for the support centre that mounting bolts for the upper structure attachment to the chair base could also have been subjected to plating conditions that may have contributed to hydrogen embrittlement.This recall action was not notified to the tga before it was initiated by a-dec australia.
  • Action
    The sponsor is advising users that the dealer will be replacing the four support centre bolts.

Device

A-dec 200 Dental Chair (examination chair)
  • Model / Serial
    A-dec 200 Dental Chair (examination chair)All batches/serial numbers manufactured since March 2011ARTG Number: 118326
  • Manufacturer
    A-DEC Australia

Manufacturer

A-DEC Australia
  • Source
    DHTGA