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
    14991
  • Date de mise en oeuvre de l'événement
    2013-07-12
  • 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
    Sample couch parameter files are supplied with monaco release 3.100 and later. the user can then access these files from the treatment couch library.By clicking on a particular couch file, the individual components of the couch can be selected and their densities edited. the user can then use the "save as treatment couch" to enter a unique name for the modified couch parameter file., when sample couch parameter files are edited, the densities altered, and "save" is selected, the sample files will be updated with these new, user defined densities. subsequently, when a software upgrade is loaded, the modified couch densities in these samples will be overwrittem with the default value of 1.000.
  • Action
    Manufacturer to issue advice regarding use

Device

Elekta Monaco Radiation Treatment Planning System
  • Modèle / numéro de série
    Model: , Affected: , Software version: 3.100 and later
  • Manufacturer
    Elekta Inc

Manufacturer

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