Events

Rappel de Varian C-Series High Energy Linear Accelerator

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 Varian Medical Systems 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
    16913
  • Date de mise en oeuvre de l'événement
    2014-07-04
  • 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: Varian Medical Systems Australasia Pty Ltd (NZ), C/- BDO Auckland - Christine Koefoed, Level 4, BDO Centre, 4 Graham Street, Auckland 1140
  • Cause
    Varian has received several reports of unexpected beam output variations with the c-series high energy [he] linear accelerator for 6mv photon treatment mode. the issue has been reported for versions 7, 8 and 9 with 6 mv configuration and maximum dose rate of at least 600 mu/min only. it was determined during intensive investigation that the 6mv target had developed a cavity or hole. degradation of the target led to beam output and symmetry changes which were not detected by the linear accelerator. the result is that a lower than intended dose could be delivered to the target volume if treatment were to take place. varian has not received any report of misadministration or injury due to this 6mv target degradation or failure.
  • Action
    Software to be upgraded

Device

Varian C-Series High Energy Linear Accelerator
  • Modèle / numéro de série
    Model: Models: Novalis Tx, Trilogy, Trilogy Tx, Clinac iX, Clinac 2100 C/D, Clinac 2300 C/D, Clinac DHX, Clinac 21EX, Clinac 23EX, Affected: , Software version: Version: 7, 8 and 9 with 6 MV configuration and maximum dose rate of at least 600 MU/min ONLY
  • Manufacturer
    Varian Medical Systems Inc

Manufacturer

Varian Medical Systems Inc