Events

Field Safety Notices about TruLight 3000/5000

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
    2016-02-16
  • Event Country
    Slovenia
  • Event Source
    AMPMDRS
  • 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 notice from a supplier that it may eventually break due to a load in the spring arm welds when exposed to high forces. trumpf medical has not received any complaints or complaints about such failure. the supplier advises performing a visual inspection of the welds every two years as suggested in the july 2010 operating instructions. the inspection should therefore be performed for all operating lights, cameras and mounting systems (mounts) for trumpf medical monitors and for suspension arms.

Device

TruLight 3000/5000

Manufacturer

TRUMPF Medizin Systeme GmbH + Co. KG