Events

Recall of Maquet Operating Table with Fixture 1002.65AO Manufactured in the period between 2009 and 2013

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Maquet 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-2016-RN-00984-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2016-07-22
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00984-1
  • 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 fixture (1002.65ao) is designed as a connecting element for the support and positioning of the patient’s head on a maquet operating table immediately before, during and after surgical interventions and as for examination and treatment. the fixture is used to adapt a range of different head rest and horseshoe head rests with a central square mount. post market surveillance reported that the welded joint between the square mount and the first fixable swivel joint had broken. as a cantilever design, this joint must bear the highest load of all welded joints. it has been determined that the breakage had been caused by ineffective welding in addition to rough handling and multiple overloading. serious injury to the patient's cervical spine may occur if the weld seam breaks during a procedure. there have been no reports of injuries as a result of this issue.
  • Action
    A Maquet service technician will be contacting customers to arrange an appointment to carry out replacement of all associated components. Until the replacement has been performed, users are advised that the device should be inspected for damage before every use. In this context, particular attention should be paid to the potential for cracks at the weld in the area illustrated in the customer letter. In case of doubt, customers are advised not to use the fixture. This action has been closed-out on 26/05/2017.

Device

Maquet Operating Table with Fixture 1002.65AO Manufactured in the period between 2009 and 2013
  • Model / Serial
    Maquet Operating Table with Fixture 1002.65AO Manufactured in the period between 2009 and 2013ARTG Number: 163023
  • Manufacturer
    Maquet Australia Pty Ltd

Manufacturer

Maquet Australia Pty Ltd
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    DHTGA