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
    25259
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2014-06-24
  • 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
    Siemens became aware of an incident with a linear accelerator oncor where an autosequence was set up with a treatment management system. during the autosequence the gantry collided with the patient's head while moving. the patient received a wound on the head that resulted in skin injuries but no further damage. the user provided a detailed report in which he described that a mistake was made when selecting the beams for autosequence. the user error caused the unintended motion and hence the injury.

Device

MEVATRON LINEAR ACCELERATORS
  • Modèle / numéro de série
    Model Catalog: 04504200 (Lot serial: 3645); Model Catalog: 01940035 (Lot serial: 3645); Model Catalog: 04504200 (Lot serial: 3641); Model Catalog: 01940035 (Lot serial: 3641); Model Catalog: 04504200 (Lot serial: 3382); Model Catalog: 01940035 (Lot serial: 3382); Model Catalog: 8139789 (Lot serial: 5414); Model Catalog: 01940035 (Lot serial: 3919); Model Catalog: 04504200 (Lot serial: 3919); Model Catalog: 01940035 (Lot serial: 2559); Model Catalog: 04504200 (Lot serial: 2559); Model Catalog: 5857912 (Lot serial: 3799); Model Catalog: 5857912 (Lot serial: 3865); Model Catalog: 7360717 (Lot serial: 5037); Model Catalog: 7360717 (Lot serial: 5041); Model Catalog: 7360717 (Lot serial: 5324)
  • 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