Events

Rappel de MEVATRON LINEAR ACCELERATORS

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par SIEMENS HEALTHCARE LIMITED.

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
    16710
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2013-06-03
  • Pays de l'événement
    Canada
  • Source de l'événement
    HC
  • Notes / Alertes
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notes supplémentaires dans les données
  • Cause
    Verifications performed identified that the dose value in "film mode" was incorrect and it was requested to stop using film mode. as a result of the incorrect dose patients may receive too much dose during image acquisition. however the overdose caused by filming is within the accepted range of deviation for dose planning and no consequences are expected unless there is a very large number of images taken.

Device

MEVATRON LINEAR ACCELERATORS
  • Modèle / numéro de série
    Model Catalog: 4504200 (Lot serial: 4173); Model Catalog: 01940035 (Lot serial: 4173); Model Catalog: 4504200 (Lot serial: 3919); Model Catalog: 01940035 (Lot serial: 3919); Model Catalog: 4504200 (Lot serial: 3742); Model Catalog: 01940035 (Lot serial: 3742); Model Catalog: 4504200 (Lot serial: 3645); Model Catalog: 01940035 (Lot serial: 3645); Model Catalog: 4504200 (Lot serial: 3641); Model Catalog: 01940035 (Lot serial: 3641); Model Catalog: 4504200 (Lot serial: 3638); Model Catalog: 01940035 (Lot serial: 3638); Model Catalog: 4504200 (Lot serial: 3619); Model Catalog: 01940035 (Lot serial: 3619); Model Catalog: 4504200 (Lot serial: 3382); Model Catalog: 01940035 (Lot serial: 3382); Model Catalog: 4504200 (Lot serial: 2618); Model Catalog: 01940035 (Lot serial: 2618); Model Catalog: 4504200 (Lot serial: 2559); Model Catalog: 01940035 (Lot serial: 2559); Model Catalog: 8139789 (Lot serial: 5485); Model Catalog: 8139789 (Lot serial: 5414); Model Catalog: 7360717 (Lot serial: 5324); Model Catalog: 7360717 (
  • Description du dispositif
    MEVATRON LINEAR ACCELERATORS
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

SIEMENS HEALTHCARE LIMITED
  • Adresse du fabricant
    OAKVILLE
  • Société-mère du fabricant (2017)
    Siemens Ag
  • Source
    HC