Events

Rappel de RayStation 3.0, 3.5, or 4.0 (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 Emergo Asia Pacific Pty Ltd T/a Emergo Australia.

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-01103-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2013-10-25
  • 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-01103-1
  • 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
    A dose calculation error has been identified in raystation versions 3.0. 3.5, and 4.0, when elekta motorised wedges are used for a beam and the wedge angle differs from 60 degrees. the error is that the modified energy spectrum has been used not only for the wedged part of the beam but also for the open part of the wedged field. for all clinical cases investigated by the manufacturer, the deviations were at the most 3-5% in the clinically relevant areas of the plan. deviations in the 10-12% range may occur in the buildup regions where dose calculations are generally considered approximate.
  • Action
    The issue will be resolved in RayStation patch 4.0.2 scheduled for market release in December 2013 and in all future releases. In the interim, workarounds for creating a beam with Elekta motorized wedge, without and with wedge optimization in described in the customer letter.

Device

RayStation 3.0, 3.5, or 4.0 (Radiation therapy treatment planning system)

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia