Events

Rappel de Oncentra External Beam (formerly known as Oncentra MasterPlan during release of v3.x)(Radiation therapy treatment planning software)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Nucletron Pty Limited.

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-2016-RN-01655-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-12-22
  • 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-2016-RN-01655-1
  • 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
    If a physical wedge, for which the total field size limit perpendicular to the wedge direction is more than 10 cm larger than the field size limit in wedge direction, is inserted in in-plane direction (as seen with collimator angle 0 degrees), then with very large fields perpendicular to wedge direction a part of the scattered fluence can become unmodulated by the wedge. this will result in profile “horns” close to the edge of the field. the deviation is most prominent with the varian 60-degree wedge. the calculated overdose in the affected areas, towards the edges of the field, is typically 6% for clinically used field sizes locally. smaller deviations inside the field can also be observed with the varian 45-degree wedge. with all other inplane wedges, including the elekta motorised wedge, there is only an insignificant deformation of the cross profile tail, which is outside the treatment field.
  • Action
    Elekta will be correcting the issue in the next upgrade of the Oncentra External Beam. In the interim, users are advised to not exceed jaw positions of +/- 12cm with the Varian 60-degree wedge and +/- 14.5 cm with the Varian 45-degree wedge in the direction perpendicular to the wedge slope, if the wedge is inserted in in-plane direction (collimator angle 0 degrees). In addition, Elekta is strongly advising users to perform proper Quality Assurance for all treatment plans before delivery of the first fraction to the patient.

Device

Oncentra External Beam (formerly known as Oncentra MasterPlan during release of v3.x)(Radiation t...
  • Modèle / numéro de série
    Oncentra External Beam (formerly known as Oncentra MasterPlan during release of v3.x)(Radiation therapy treatment planning software)All versionsARTG Number: 142110
  • Manufacturer
    Nucletron Pty Limited

Manufacturer

Nucletron Pty Limited