Events

Rappel de ERGO version 1.7.3 and higher and using a Multileaf Collimator (MLC) device for planning

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-2017-RN-01283-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2017-10-13
  • 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-2017-RN-01283-1
  • 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
    Elekta has become aware of the potential for incorrect dicom mapping of the exported collimator or couch angles from ergo. this would lead to incorrect rotation of the collimator or couch when using a mlc device for planning.If the dicom export values are not mapped correctly, it is possible that treatments could be delivered with the wrong collimator or couch angle. in the event patients were treated with the wrong collimator or couch angle, this would result in a geometric miss with the tumour being potentially under-dosed and normal structures overdosed.
  • Action
    Elekta is advising users who are using MLC for dose planning in ERGO to run a verification test to ensure that the collimator and couch are rotating correctly. If the verification test fails please contact the Elekta Care Support Centre for assistance.

Device

ERGO version 1.7.3 and higher and using a Multileaf Collimator (MLC) device for planning
  • Modèle / numéro de série
    ERGO version 1.7.3 and higher and using a Multileaf Collimator (MLC) device for planningARTG Number: 187299
  • Classification du dispositif
    Radiology Devices
  • Manufacturer
    Elekta Pty Ltd

Manufacturer

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