Events

Rappel de RayStation and RayPlan

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-2018-RN-00128-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2018-02-23
  • 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-2018-RN-00128-1
  • 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 manufacturer has identified that when more than one beam is defined on the same isocenter, the center beam in field (cbf) affects all beams in a way that the user may not expect.After using cbf, the resulting fields are clearly displayed in raystation/rayplan for review and approval. however, one mistreatment incident using the cbf functionality has been reported where the user failed to review the resulting beam apertures before treatment delivery.
  • Action
    Emergo will be contacting users to update to the next version of RayStation/RayPlan. In the interim, users are advised: · Be aware that Center Beam in Field affects all beams that share the same isocenter and that apertures may be modified in a way not intended. · Do not use Center Beam in Field after having created an opposed beam. If an opposed beam has been created, delete the opposed beam and use Center Beam in Field on the remaining beam. Then recreate the opposed beam.

Device

RayStation and RayPlan
  • Modèle / numéro de série
    RayStation and RayPlanModel Numbers: RayStation 4.9 (RayPlan 1), RayStation 5, RayStation 6 (RayPlan 2) andRayStation 7 (RayPlan 7)Serial Numbers: 4.9.0.42, 5.0.0.37, 5.0.1.11, 5.0.2.35, 6.0.0.24, 6.1.0.26, 6.1.1.2, 6.2.0.7 or7.0.0.19ARTG Number: 195288(Emergo Asia Pacific Emergo Australia - Radiation therapy treatment planning system)
  • Manufacturer
    Emergo Asia Pacific Pty Ltd T/a Emergo Australia

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia