Field Safety Notices about TruLight 3000, TruLight 5000, iLED 3, iLED 5 and TruVidia

According to Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), this field safety notices involved a device in Slovenia that was produced by TRUMPF Medizin Systeme GmbH + Co. KG.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Date
  • Event Country
  • Event Source
  • Notes / Alerts
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • Extra notes in the data
  • Reason
    Trumpf medical has received information that separates iled and trulight lighting systems from central axes and as a result they fall to the ground. the attachments occurred while installing the lights in preparation for surgery. the crash resulted in a single user being injured.


  • Model / Serial
    iLED Single 4028110 iLED Duo 4028210 iLED Trio / Quad 4028310 TruLight Single 4038110 TruLight Duo 4038210 TruLight Trio / Quad 4038310 iLED Single (US / Canada only) 1565068 iLED Duo (US / Canada only) 1565160 iLED Trio / Quad (US / Canada only) 1565161 TruLight Single (US / Canada only) 1574759 TruLight Duo (US / Canada only) 1574850 TruLight Trio / Quad (US / Canada only) 1574851 TruVidia Arm 1532466
  • Manufacturer