Events

Rappel de Elekta Monaco 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 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
    20522
  • Date de mise en oeuvre de l'événement
    2016-08-22
  • 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
    In a specific workflow where contours are edited (enlarged, moved, copied etc;) and then the contour is deleted on some slices and saved in the same session, it is possible that the deleted contours are still present which would not be the intent of the planner., if the patient is not saved and recalled, in a subsequently created plan the bev will show the contours as still present while the transverse, sagittal and coronal views will show the contours as deleted., if the user bases their clinical devisions on incorrect contours it could lead to dose erors and potential patient mistreatments.
  • Action
    Manufacturer to issue advice regarding use

Device

Elekta Monaco RTP
  • Modèle / numéro de série
    Model: , Affected: , Software version: 3.1 amd higher
  • Manufacturer
    Elekta Inc

Manufacturer

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