Events

Rappel de Secondary 19" Touchscreen - TEGRIS System (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-2013-RN-00851-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-08-09
  • 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-2013-RN-00851-1
  • 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
    A tegris system that has a second touch monitor used to operate the operating room (or) table, is not equipped with an emergency stop button. in an unlikely event of malfunction of the table control module, which could lead to unexpected movement of the or table, this secondary touch monitor could not be used to stop the table in an emergency situation. thus, the intended immediate stop of the table movement could be delayed.
  • Action
    Maquet is providing instructions to the user to disconnect both the primary and secondary touch screens from the OR table. The table can still be controlled by the corded or infrared hand control. A second emergency stop button will be installed on all existing and future secondary touch screens, which will be available in Australia in October 2013.

Device

Secondary 19" Touchscreen - TEGRIS System (Operating room device management system)
  • Modèle / numéro de série
    Secondary 19" Touchscreen - TEGRIS System (Operating room device management system)Part number: 1707.05A0ARTG number: 185134
  • Manufacturer
    Maquet Australia Pty Ltd

Manufacturer

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