Events

Rappel de Tegris OR Table Control (Operating room device management system)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Maquet Australia 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-2014-RN-00917-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-08-20
  • 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-2014-RN-00917-1
  • 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
    Maquet has identified a potential issue that might occur with the tegris software module for operating room (or) table integration. the fault is only relevant for customers with a license for the or table control 1703.35a0 module and use it to integrate the magnus operating table system.The button commands for "lower leg up" and "leg down" have been switched in the software for the integration of the magnus operating table system. as a result, when these functions are activated on the tegris touchscreen, the wrong movement is executed. thus far, no incidence has been reported in which a person has been injured or endangered.
  • Action
    Maquet Australia is advising the customers to discontinue using the Tegris OR Table Control in conjunction with MAGNUS that is equipped with a software version up to 2.1.x.x,. The problem has been resolved as of version 2.2.x.x. A Maquet Service Technician will provide a software update to resolve this issue. This action has been closed-out on 18/03/2016.

Device

Tegris OR Table Control (Operating room device management system)
  • Modèle / numéro de série
    Tegris OR Table Control (Operating room device management system)Part number: 1703.35A0All software versions up to 2.1.x.x are affectedARTG Number: 185134
  • Manufacturer
    Maquet Australia Pty Ltd

Manufacturer

Maquet Australia Pty Ltd
  • Société-mère du fabricant (2017)
    Getinge AB
  • Source
    DHTGA