Events

Rappel de Elekta X-Ray Volume Imaging System (XVI)

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 Limited (England).

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
    15809
  • Date de mise en oeuvre de l'événement
    2014-10-17
  • 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 xray volume imaging system (xvi) can incorrectly calculate the target position of the treatment table, because of an error due to a specific sequence of events that does not occur very frequently., if patient and treatment table movements are not monitored ,and the automatic setup buttons are kept pressed ,the treatment table continues to move. it only stops when a touchguard activates. therefore this error can cause a collision between the patient and an external beam limiting device. if this error occurs with an external beam limiting device attached to the digital accelerator, it may cause fatal injury to the patient.
  • Action
    Software to be upgraded

Device

Elekta X-Ray Volume Imaging System (XVI)
  • Modèle / numéro de série
    Model: , Affected: , Software version: R4.5, R4.5.1, R4.6 to R5.0
  • Manufacturer
    Elekta Limited (England)

Manufacturer

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