Events

Recall of MAQUET HLX 2004-5 DF, HLX 3004-5 DF and XTEN DF cupolas Surgical Lighting System(used with ONDAL Acrobat 2000 Spring Arms manufactured between Jan 2004 - Dec 2006)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Getinge 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-2017-RN-01394-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-11-14
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01394-1
  • 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
    It has been concluded that there is a low failure rate that only can present itself on the devices of types and production identified in this letter. the issue relates to a crack in the metal of the spring arms that has the potential develop into a break. this potential for malfunction is caused by fissures near the weld seam at the front pivot of the spring arm. the design of the spring arm was improved in 2006. the devices are over ten years old and even so the vast majority have not failed. there have been related complaints, however to date no events involving injury have been reported.
  • Action
    Getinge is advising users that all potentially affected spring arms will be replaced with new spring arms.

Device

MAQUET HLX 2004-5 DF, HLX 3004-5 DF and XTEN DF cupolas Surgical Lighting System(used with ONDAL ...
  • Model / Serial
    MAQUET HLX 2004-5 DF, HLX 3004-5 DF and XTEN DF cupolas Surgical Lighting System(used with ONDAL Acrobat 2000 Spring Arms manufactured between Jan 2004 - Dec 2006)Multiple part numbers affectedARTG Number: 162037 (Getinge Australia Pty Ltd - Light, surgical)
  • Manufacturer
    Getinge Australia Pty Ltd

Manufacturer

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