Events

Recall of iLED 3/5, TruLight 3000/5000, Helion, TruVidia SD, TruVidia HD, VidiaPort Surgical Lighting, Camera and Monitoring Systems

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Trumpf Med Aust 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-2016-RN-00458-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-04-22
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00458-1
  • 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
    Trumpf medical has been notified by its supplier that there is potential for fatigue fractures to develop in welds of spring arms over time when subject to extreme forces. there is a risk the monitor could fall and swing freely on the swing arm and strike a person or object. there have been no reports of injuries as a result of this issue.
  • Action
    Trumpf Medical is advising users that if the systems are due for biennial maintenance, to contact the authorised service provider to schedule the preventative maintenance. If the biennial maintenance is not due, and the service provider did not inspect the welds during the previous maintenance, contact the service provider to schedule a service call to inspect the welds. Requirements to inspect the welds during biennial maintenance can be found in the User Manual.

Device

iLED 3/5, TruLight 3000/5000, Helion, TruVidia SD, TruVidia HD, VidiaPort Surgical Lighting, Came...
  • Model / Serial
    iLED 3/5, TruLight 3000/5000, Helion, TruVidia SD, TruVidia HD, VidiaPort Surgical Lighting, Camera and Monitoring Systems All Serial Numbers affectedARTG Numbers: 200921, 200946, 200943, 200945,170219, 170545
  • Manufacturer
    Trumpf Med Aust Pty Ltd

Manufacturer

Trumpf Med Aust Pty Ltd