Events

Rappel de iGUIDE with software version 2.2.0 (used with HexPOD evo RT System, used for accurate patient positioning during radiation therapy treatment)

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-2016-RN-01116-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-08-25
  • 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-2016-RN-01116-1
  • 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
    Iguide monitors if the hexapod is in the pre-defined 3d position. if it is not in this position an inhibit is set. for 3d treatments there is no iguide interlock check possible. in the event of a malfunction of the interlock system an inhibit in iguide may not lead to an external inhibit on the linac. there is the potential for unrecognised incorrect position of the treatment couch in 3d workflow, i.E. the hexapod has not moved fully to the 3d position.
  • Action
    Elekta is advising user that if users do not intend to use iGUIDE for patient positioning, make sure the HexaPOD is at its pre-defined 3D position before treatment. The 3D position is confirmed in the iGUIDE login screen (no inhibit icon) or in the iGUIDE System Overview. In addition the External Inhibit LED at the Enable Switch Board must be off. It is recommended to perform the Interlock Check in the iGUIDE software on a daily basis. This information has been included in the Instructions For Use (IFU). This action has been closed-out on 09/05/2017.

Device

iGUIDE with software version 2.2.0 (used with HexPOD evo RT System, used for accurate patient pos...
  • Modèle / numéro de série
    iGUIDE with software version 2.2.0 (used with HexPOD evo RT System, used for accurate patient positioning during radiation therapy treatment) ARTG Number: 187340
  • Manufacturer
    Elekta Pty Ltd

Manufacturer

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