Events

Recall of Maquet PowerLED, HLED 700 SF and Volista 600SF Surgical Lighting Systems

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-00120-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-02-07
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00120-1
  • 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 manufacturer, getinge, has received complaints concerning unintentional drifting of the cupola during surgery due to prematurely worn out brake screws. the observed movement is a slow rotation of the cupola around the axis, potentially shifting the light patch away from the wound.Clinical evaluations concluded that there is a low risk of injury or other health consequences expected for the patient or the user. only one (i.E. the heavier) cupola of a configuration is concerned by the malfunction, and the second cupola provides sufficient illumination of the surgical area if the issue occurs during surgery.
  • Action
    Getinge is advising users that a service technician will be correcting all affected units.

Device

Maquet PowerLED, HLED 700 SF and Volista 600SF Surgical Lighting Systems
  • Model / Serial
    Maquet PowerLED, HLED 700 SF and Volista 600SF Surgical Lighting SystemsManufactured between August 2009 and July 2014Multiple Part Numbers affected ARTG 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