Events

Rappel de Monaco (with the use of Elekta Motorised Wedges)

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-00051-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-01-10
  • 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-00051-1
  • 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
    An issue has been identified where the calculated dose from wedged beams can be assigned to the wrong beam. this can occur for a plan with at least two beams using the elekta motorised wedge. as a consequence, a geometric miss would result with the dose distribution not reflecting what is delivered to the patient.
  • Action
    As a temporary fix, Elekta is advising users to change the beam index numbers belonging to the two wedged beams, such that the index numbers are exchanged for these beams, then edit the wedge angle of one of the beams. The problem will resolve itself if a recalculation is forced after the beam numbers are edited and the wedge angle is modified, A permanent fix in the form of a software update is anticipated to be released by the end of May 2017.

Device

Monaco (with the use of Elekta Motorised Wedges)
  • Modèle / numéro de série
    Monaco (with the use of Elekta Motorised Wedges)Software versions: V 5.10.00 (including 5.10.01, 5.10.02)V 5.11.00 (including 5.11.01)V 5.20.00ARTG Number: 215960
  • Manufacturer
    Elekta Pty Ltd

Manufacturer

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