Events

Rappel de Elekta Monaco Radiation therapy treatment planning system

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 Elekta Inc.

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
    17182
  • Date de mise en oeuvre de l'événement
    2014-08-15
  • 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
    When dicom exporting an arc plan (vmat, dynamic conformal or 3d static arcs) and using the composite field sequencing (cfs) feature, the dicom exported plan will not match the approved treatment plan., the problem occurs when the starting gantry angle of the second arc is exactly 180 degrees and the stop angle of first beam is greater than 180 degrees away from the start position of the second arc. cfs is designed to combine arcs into a single beam to streamline delivery. however, under these specific circumstances, the start and stop points for the arcs become corrupted.
  • Action
    Software to be upgraded

Device

Elekta Monaco Radiation therapy treatment planning system
  • Modèle / numéro de série
    Model: , Affected: , Software version: Monaco 3.20.00 and higher when using Elekta or Siemens linacs
  • Manufacturer
    Elekta Inc

Manufacturer

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