Events

Rappel de Varian RPM Respiratory Gating 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 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
    14570
  • Date de mise en oeuvre de l'événement
    2013-04-29
  • 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
    Manufacturer has identified an anomaly with the rpm respiratory gating system. while operating with the 6-dot marker block, this version of the rpm gating may produce an inverted respiratory waveform in amplitude and phase-gating sessions., the error may be reproduced if the rpm system is induced to frequently lose and re-acquire tracking of the 6-door marker block during a calibration sequence, a reference session or a single session after tracking has begun.
  • Action
    Software to be upgraded

Device

Varian RPM Respiratory Gating System
  • Modèle / numéro de série
    Model: H50, Affected: 1.7.5 with 3D option SN's: H501056, H501080, H501944, H502289, H502300, H502301, H503567, H503596, H503935, H504201 and H504724.
  • Manufacturer
    Varian Medical Systems Inc

Manufacturer

Varian Medical Systems Inc