Events

Recall of VOLISTA STANOP, TRIPOD, ACCESS and QUICKLOCK Light heads

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-2018-RN-00656-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-05-31
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00656-1
  • 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
    Getinge has identified that a screw is missing from the racket of the cupola on some devices in production. it is not yet confirmed whether the screw was missed during manufacture or had loosened over the life of the device. as a consequence the light head shaft could break and the cupola could detach itself when manipulated and be held only by its cables. it appears such event is more likely to happen mainly during maintenance, cleaning and surgery preparation.
  • Action
    Getinge are advising they will contact affected sites to plan for update of devices. In the interim, users should verify whether the cupola has mechanical play by following the guidance provided in the Customer Letter. If no play in the cupola is detected the device may continue to be used. If play is detected, users should cease use of the device and contact Getinge immediately.

Device

VOLISTA STANOP, TRIPOD, ACCESS and QUICKLOCK Light heads
  • Model / Serial
    VOLISTA STANOP, TRIPOD, ACCESS and QUICKLOCK Light heads All units manufactured until December 2016Light Head Part Numbers: ARD568811950, ARD568811960, ARD568811961, ARD568811962, ARD568812910, ARD568812950, ARD568812960, ARD568812962, ARD568821913, ARD568821960 and ARD568822960ARTG Number:162037
  • Manufacturer
    Getinge Australia Pty Ltd

Manufacturer

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