Events

Rappel de Eclipse Treatment Planning System, (Radiation therapy treatment planning system), version 11Version 11 with PBC 11.0.21, 11.0.30

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Varian Medical Systems Australasia 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-00105-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2013-02-04
  • 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-00105-1
  • 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
    The final calculated dose of dose dynamic fields will be incorrect when both conditions occur:1. the pencil beam convolution [pbc] 11 algorithm license feature is used,2. either the energy and/or the treatment unit of a dose dynamic field, differs fromthat of the first created treatment field in the plan.Under these conditions, the final dose calculation will determine the mu to dose calibration (mugy10) factor and the applicable dose rate table value (csbf coefficient) using the energy of the first treatment field (in the order of creation) for all dose dynamic fields, regardless of the actual field energy.
  • Action
    Varian Medical Systems is requesting users to not use the Pencil Beam Convolution (PBC) 11 algorithm for dose dynamic plans. It is recommended that dynamic MLC plans are calculated with the AAA or Acuros XB algorithm. PBC versions prior to version 11 can still be used. Varian recommends a review of treated patient plans where the PBC 11 algorithm was used for the calculation of dose dynamic plans. A technical correction is under development and will be implemented once complete.

Device

Eclipse Treatment Planning System, (Radiation therapy treatment planning system), version 11Versi...

Manufacturer

Varian Medical Systems Australasia Pty Ltd