Events

Recall of TruLight 3000, TruLight 5000, iLED 3, iLED 5 and TruVidia Lighting and Video 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-2015-RN-01250-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-12-24
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01250-1
  • 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 received information stating the iled and trulight lighting systems have fallen from the central axis. the reported incidents occurred while the lights were being positioned for surgical procedures and have been involved in one injury to a user. the investigation of this issue has determinedthe root cause is due to the improper installation of the snap ring that can occur when a spring arm is attached to the central axis. the snap ring is located inside the interface and holds the spring arm in place. if the snap ring is installed improperly, the spring arm of the lighting system can descend over time, and eventually fall from the central axis. when the snap ring has been installed properly, the potential for the lighting system to fall does not exist.
  • Action
    Hill-Rom is providing users with work around instructions to follow as an interim measure. Hill-Rom will be inspecting affected units and providing additional labelling as a permanent measure.

Device

TruLight 3000, TruLight 5000, iLED 3, iLED 5 and TruVidia Lighting and Video Systems
  • Model / Serial
    TruLight 3000, TruLight 5000, iLED 3, iLED 5 and TruVidia Lighting and Video SystemsMultiple products and serial numbers affectedARTG Numbers: 200921, 170219 and 170545
  • Manufacturer
    Trumpf Med Aust Pty Ltd

Manufacturer

Trumpf Med Aust Pty Ltd