Events

Rappel de Elekta Monaco Radiation 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
    19289
  • Date de mise en oeuvre de l'événement
    2015-10-21
  • 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
    Two identified issues:, 1- in version 5.10.01, the isodose control 100% isodose value was linked to the dose normalization value so users would always have a known normalization value linked to 100% when in relative mode. this however limits the user to only one defined value available above 100%. when the 100% isodose value is edited on the isodose control, the dose normalization is automatically updated. if the user does not notice this update and then rescales to a relative isoline and does not read the dose normalization value displayed on the rescale bar, the rescale could be other than intended., , 2-when the user optimizes, then changes the bolus assignment of the beams, and then selects "calculate" (not "optimize" again), the bolus assignment to beams can get scrambled. beams that should have bolus assigned do not and beams that do not have bolus assigned calculate with bolus. the dose distribution and monitor units are incorrect for the bolus assignment of the beams.
  • Action
    Software to be upgraded

Device

Elekta Monaco Radiation Treatment Planning System
  • Modèle / numéro de série
    Model: , Affected: , Software version: 5.10 and higher
  • Manufacturer
    Elekta Inc

Manufacturer

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