Events

Rappel de Varian Clinac, Trilogy, Trilogy Tx, Novalis Tx, and Unique Accelerators

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
    15626
  • Date de mise en oeuvre de l'événement
    2013-11-06
  • 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
    Events have been reported in which a user has remotely rotated the gantry into contact with the couch or with patients, in both the manual mode and the automated mode. in one event, a patient was reported injured when the user operating the gantry in manual mode, rotated the gantry of a clinac® 21ex into physical contact with the patient's pelvis. this event involved use of remote manual control of gantry rotation (i.E. controlled manually from outside the treatment vault). such a motion is not a preprogrammed motion and is exclusively under the control of the operator.
  • Action
    Software to be upgraded

Device

Varian Clinac, Trilogy, Trilogy Tx, Novalis Tx, and Unique Accelerators
  • Modèle / numéro de série
    Model: Product Codes: H14, H18, H27, H29, Affected: Versions: 7.x, 8.x, 9.0
  • Manufacturer
    Varian Medical Systems Inc

Manufacturer

Varian Medical Systems Inc