Events

Rappel de Oncentra Brachy using versions 4.5, 4.5.1 and 4.5.2

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-2017-RN-01069-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-08-16
  • 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-2017-RN-01069-1
  • 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
    Elekta has identified an issue with oncentra brachy with the default step size set in rdstore.The measured source paths for a ring-type applicator have a source step size of 2.5mm for the microselectron afterloader. when creating a plan for a ring applicator with a measured source path, the step size will be used for the entire plan. if such an applicator model is used while the default step size of the afterloader is 5.0, the step size in the ring or lunar-shaped ovoids will be incorrect. they will be shown as 2.5mm, while the afterloader will deliver at 5.0mm if the error is not detected during plan approval.If this plan is exported to the microselectron treatment control system (tcs) and delivered, the treated dwell positions in the ring will be incorrect. when loading the plan in tcs only the dwell position numbers and source step size are taken over from the oncentra brachy plan. this leads to a shift of the treated dwell positions in the ring due to the incorrect step size.
  • Action
    Until an upgraded version of Oncentra Brachy is available, users are strongly recommended to use a default source step size of 2.5mm for microSelectron afterloaders in RDStore. If a larger default source step size is required in RDStore, a workaround is to reselect the same after loader in the Prescription dialog in the Oncentra Brachy planning module. The source step size is then forced to the correct value of 2.5mm. Users are advised to perform proper Quality Assurance for all treatment plans before delivery of the first fraction to the patient. The issue will be solved in the next version of Oncentra Brachy.

Device

Oncentra Brachy using versions 4.5, 4.5.1 and 4.5.2
  • Modèle / numéro de série
    Oncentra Brachy using versions 4.5, 4.5.1 and 4.5.2Reference Number: FCA-NU-0004ARTG Number: 142110
  • Manufacturer
    Nucletron Pty Limited

Manufacturer

Nucletron Pty Limited