Events

Recall of MAQUET VOLISTA central handle on StanOP, TRIPOD and ACCESS Cupolas

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-00045-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-01-16
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00045-1
  • 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 received complaints indicating that the central handle holder detaches easily from the cupola during use. we determined that the root cause of this malfunction is excessive tightening of the screws during mounting of the handle holder, resulting in the rivets loosening and detaching from the central handle holder ring.During manipulation, the handle holder may completely detach from the light head, if all three rivets loosen simultaneously. in this case, although the handle remains in the user’s hand, small quantities of particles may be generated from the plastic holder ring.
  • Action
    Getinge will be in contact with affected users to arrange for a service technician to replace existing central holder rings.

Device

MAQUET VOLISTA central handle on StanOP, TRIPOD and ACCESS Cupolas
  • Model / Serial
    MAQUET VOLISTA central handle on StanOP, TRIPOD and ACCESS Cupolas Part Numbers: ARD568811950, ARD568811960, ARD568811961, ARD568811962, ARD568812910, ARD568812950, ARD568812960, ARD5688112962, ARD568821913,Serial Numbers (up to, for the above part numbers respectively): 50000, 500063, 500003, 500030, 500004, 50000, 500046, 500007, 500001ARTG 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