Events

Rappel de iPlan RT Dose version 4.0 and 4.1 (including all subversions) (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 Brainlab Australia 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-00339-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-04-19
  • 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-00339-1
  • 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
    Iplan rt dose version 4.0 and 4.1 might not correctly refresh the dose calculation after certain mlc shape modifications if all of the following conditions are met:- the modifications are performed for a dynamic conformal arc, and- the jaw positions are defined manually, and- the dose display (e.G. isodose lines) is turned on, or if the dose has already been calculated and the dose display is turned on again after the mlc shape was modified. the effect may occur for the following modifications of the mlc shape: - the mlc margin of the arc is modified- the mlc shape is modified in the beam’s eye view (bev) in a way that also changes the mlc shapes of neighbouring segments of the arc1- the leaf adaption is modified (inline/average/outline)- the modified mlc shapes in the bev are resetthe dose calculation is not refreshed in the physician’s review and physicist’s verification tasks or when generating the printout or exporting the plan.
  • Action
    Brainlab is providing work around instructions and is developing a software update to permanently correct the problem.

Device

iPlan RT Dose version 4.0 and 4.1 (including all subversions) (Radiation therapy treatment planni...
  • Modèle / numéro de série
    iPlan RT Dose version 4.0 and 4.1 (including all subversions) (Radiation therapy treatment planning system)ARTG Number: 121114
  • Manufacturer
    Brainlab Australia Pty Ltd

Manufacturer

Brainlab Australia Pty Ltd