Events

Rappel de XiO versions 4.50 and higher (Radiation therapy treatment planning system)

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-2013-RN-01278-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2013-11-29
  • 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-2013-RN-01278-1
  • 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
    When computing the effective depth (with bolus) to the weight point during treatment planning, xio could use the bolus density for a particular segment of the weight fan when it should be using the ct density. if the ct density is different than the bolus density, the effective depth will be incorrect which will lead to incorrect dose. the problem occurs when the computation of the bolus polygon incorrectly invades the patient contour and overlaps an area where the ct density is much different than bolus density. when the dose is computed along each fanline/depthline, an area of bolus-patient overlap is detected, the incorrect density could be assigned. there is a remote probability of a mistreatment resulting in serious injury.
  • Action
    Elekta is advising users that if all fractions are bolused, a workaround would be to scan the patient with the bolus in place. The incorrect assignment of density to areas of bolus-patient overlap was introduced in XiO Release 4.50.00 and will be resolved in Patch Release 4.80.03 and release 5.00.01. Patch Release 4.80.03 is now available (ie, Jan 2014) and release 5.00.01 is expected to be available by March 2014. This action has been closed-out on 11/02/2016.

Device

XiO versions 4.50 and higher (Radiation therapy treatment planning system)
  • Modèle / numéro de série
    XiO versions 4.50 and higher (Radiation therapy treatment planning system)ARTG Number: 99769
  • Manufacturer
    Elekta Pty Ltd

Manufacturer

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