Field Safety Notices about JUPITER, ARTIS and TruSystem 7500

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 reports that in some cases the above operating tables were moving automatically and without conscious use of the remote control. no injuries to patients or users. reported cases suddenly occurred during preparation or surgery. through individual investigations, each time it was determined that the problem was a button on the remote control that was mechanically damaged by external influences. the defective key corresponded to the reported direction of movement each time. key injuries may have occurred due to e.G. collision with other objects or compression between moving parts. as a result, the remote control can, at any time, permanently or temporarily transmit a movement command at a time when a particular shake or movement occurs. the operating table cannot differentiate the throw with such and the desired movement commands. based on investigations, trumpf medical has determined that remote controls were used controls that show clear damage and are therefore no longer permitted to use. automatic movement can be prevented by proper inspection before use.