Field Safety Notices about 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
  • 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
    During testing, trumpf medical found that the radiated emissions from the truvidia ™ wireless receiver exceeded the regulatory limits. it is unlikely, but it is possible that the radiated emissions will affect other devices in the operating room, which could cause other devices to malfunction. the frequency of interference and associated risks will depend on the immunity of other devices to the emitted emissions and the nature of the equipment error in the operating room used at that time. trumpf medical has not received any complaints or allegations of injuries related to the issue.