Events

Rappel de Varian VariSource TM iX Console software with magnetic hard disk drive only

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 Haan GmbH.

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
    18584
  • Date de mise en oeuvre de l'événement
    2015-05-28
  • 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
    Varisource ix console software version 1.2, build 2.4336 will occasionally freeze during the treatment initiation sequence. an application freeze is a condition when, after pressing the deliver treatment button the the treatment delivery strip, the treatment delivery strip becomes blank and the afterloader remains in idle mode and does not switch to treatment delivery mode. no other buttons on the control software user interface will respond. as a consequence of a system freeze there is the potential for the partial fraction generated by the system to be incorrect.
  • Action
    Software to be upgraded

Device

Varian VariSource TM iX Console software with magnetic hard disk drive only

Manufacturer

Varian Medical Systems Haan GmbH