Events

Rappel de Remote controls for JUPITER, ARTIS and TruSystem 7500 operating tables

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Trumpf Med Aust Pty Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2015-RN-00182-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-03-13
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00182-1
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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
  • Modèle / numéro de série
    Remote controls for JUPITER, ARTIS and TruSystem 7500 operating tables
  • Manufacturer
    Trumpf Med Aust Pty Ltd

Manufacturer

Trumpf Med Aust Pty Ltd