Events

Recall of Remote controls for JUPITER, ARTIS and TruSystem 7500 operating tables

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-00182-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-03-13
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00182-1
  • 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 received reports that the operating tables sporadically moved independently and without the user deliberately pressing an operating element. no patients or users were injured. the investigations determined that the root cause was a button on a remote control which was mechanically damaged by external influences. as a result of the damaged button, specific vibrations or movements of the remote control can emit a valid movement command at any time, either continuously or sporadically.This action was undertaken prior to the notification to the tga.
  • Action
    Trumpf Medical is providing instructions as a supplement to the user manual and requesting the users to check the remote controls for visual damages.Trumpf Medical is requesting the customers to avoid using the remotes with visual damages to the key pads.Trumpf Medical is arranging the upgrade of the existing remote controls with a redesigned membrane keypad to eliminate the known mode of failure. This action has been closed-out on 19/02/2016.

Device

Remote controls for JUPITER, ARTIS and TruSystem 7500 operating tables
  • Model / Serial
    Remote controls for JUPITER, ARTIS and TruSystem 7500 operating tables
  • Manufacturer
    Trumpf Med Aust Pty Ltd

Manufacturer

Trumpf Med Aust Pty Ltd