Events

Rappel de Monaco V 5.11 and V 5.20 (used for radiation treatment 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-2016-RN-01421-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-11-03
  • 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-2016-RN-01421-1
  • 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
    It has been identified that when running monaco v 5.11 or v.5.20 and creating 3d plans and using elekta motorized wedges, that the dose can be incorrectly calculated when using the reset function in monaco. when creating 3d plans using dose weighting mode, if the user rescales the plan, selects “reset”, and then changes the wedge angle, the plan dose and monitor units (mu) should be returned to the original values before the rescale. instead, the system correctly restores the edited wedge field but incorrectly applies the scale reset value again to all other beams in the plan. the clinical impact is that the mus are correct for the non-wedged beams but the dose being presented on the screen is incorrect. therefore the dose displayed will not be what is delivered.
  • Action
    Elekta is advising users that the issue will be resolved with Monaco software releases V 5.11.02 and 5.30, which have estimated release dates of end of January 2017 and end of March 2017, respectively. Elekta is also advising users that, in the interim, the problem can be avoided by forcing a Monaco recalculation (change dose calculation grid spacing and change back) when any wedge angle change is made.

Device

Monaco V 5.11 and V 5.20 (used for radiation treatment planning)
  • Modèle / numéro de série
    Monaco V 5.11 and V 5.20 (used for radiation treatment planning) ARTG Number: 215960
  • Manufacturer
    Elekta Pty Ltd

Manufacturer

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