Events

Rappel de Oncentra RTP

Selon New Zealand Medicines and Medical Devices Safety Authority, ce/cet/cette rappel concerne un dispositif en/au/aux/à New Zealand qui a été fabriqué par Nucletron BV.

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
    21821
  • Date de mise en oeuvre de l'événement
    2017-08-17
  • Pays de l'événement
    New Zealand
  • Source de l'événement
    NZMMDSA
  • URL de la source de l'événement
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alertes
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notes supplémentaires dans les données
    Recalling Organisation: Elekta Pty Limited - New Zealand Branch, Level 2, Windsor Court , 128-136 Parnell Road, Parnell, AUCKLAND 1052
  • Cause
    The default step size set in rdstore is typically used during the planning process. the measured source paths for a ring-type applicator always have a source step size of 2.5 mm for the microselectron afterloader. when creating an oncentra brachy plan for a ring applicator with a measured source path, the step size of the measured source path will be used for the entire plan., the issue is caused by the measured source paths for the applicators listed below, which have a source step size of 2.5 mm for the microselectron afterloader. if you use such an applicator model to create a plan, 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 2.5 mm, while the afterloader will deliver at 5.0 mm if the error is not detected during plan approval.
  • Action
    Software to be upgraded

Device

Oncentra RTP
  • Modèle / numéro de série
    Model: , Affected: Oncentra Brachy versions 4.5, 4.5.1, 4.5.2.
  • Manufacturer
    Nucletron BV

Manufacturer

Nucletron BV
  • Société-mère du fabricant (2017)
    Elekta AB
  • Source
    NZMMDSA