Events

Recall of Getinge VOLISTA StandOP and TRIPOD surgical lights

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-00282-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-03-27
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00282-1
  • 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 an issue causing failure of the control keypad resulting in the cupola not turning on or off. a review of complaint data has demonstrated that this issue has occurs in 3 different keypad versions. this potential for malfunction is caused by an internal frequency issue of a component on keypads version 1, and by the touch-sensitive technology that was not sensitive enough on versions 2 and 3. the keypads at fault are no longer produced. getinge have implemented a more robust keypad using a different technology. this action is to replace the potentially defective keypads with the new keypad.To date, no injuries as a result of this issue have been reported.
  • Action
    Getinge is advising they will contact affected users to schedule a service to replace any potentially defective keypads with the new keypad.

Device

Getinge VOLISTA StandOP and TRIPOD surgical lights
  • Model / Serial
    Getinge VOLISTA StandOP and TRIPOD surgical lights Model Codes: VOLISTA 400 and VOLISTA 600Manufactured before June 2017Keypad Part Number: ARD568801560Up to Serial Number: 540000Device Part Numbers: ARD568811950, ARD568811960, ARD568811961, ARD568811962, ARD568812910, ARD568812950, ARD568812960, ARD568812962, ARD568821913, ARD568821960, ARD568821963, ARD568822960, ARD568822963ARTG Number: 162037(Getinge Australia - Light, surgical)
  • Manufacturer
    Getinge Australia Pty Ltd

Manufacturer

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