Events

Rappel de HexaPOD evo RT Systems running iGUIDE 2.0.0 - 2.0.2 (used for accurate patient positioning within a radiation therapy treatment environment)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Elekta 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-00612-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2014-06-03
  • 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-00612-1
  • 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
    The iguide key allows to the treatment of patients without using the hexapod evo rt system. when users turn the iguide key to the off position; the external inhibit signal is overridden and the iguide software closes any open fractions and logs off (login appears). in some circumstances, a bug in the iguide software prevents the iguide software from logging off. the iguide software looks like it can be used for positioning, but it is no longer running correctly. even when users turn the iguide key back to the on position, it will not set the external inhibit signal or alert them if the position has changed (ie, position guard is inactive). this problem can lead to clinical mistreatment if the user assumes that the iguide software is running correctly. the iguide software will not set the external inhibit signal or notify the user in case of incorrect positioning or movements.
  • Action
    Users should only use the iGUIDE software when the key is in the on position and the Position Guard is active. Users are advised to restart the workstation if any error occurs to ensure the software is running properly. A software update will be implemented on all affected systems that corrects the behaviour of the iGUIDE software. This action has been closed-out on 11/02/2016.

Device

HexaPOD evo RT Systems running iGUIDE 2.0.0 - 2.0.2 (used for accurate patient positioning within...
  • Modèle / numéro de série
    HexaPOD evo RT Systems running iGUIDE 2.0.0 - 2.0.2 (used for accurate patient positioning within a radiation therapy treatment environment)ARTG Number: 187340
  • Classification du dispositif
    Radiology Devices
  • Manufacturer
    Elekta Pty Ltd

Manufacturer

Elekta Pty Ltd
  • Société-mère du fabricant (2017)
    Elekta AB
  • Source
    DHTGA