Events

Rappel de OPTICAL GUIDANCE PLATFORM - FASTPLAN SYSTEM

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada 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
    19938
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2010-05-06
  • 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
    Note: series date parameter is optional and not found on all systems. mr misalignment in cone planning could be consistently encountered on any datasets where mr data has an empty (0008 0021) series date dicom element. while the mr image could be correctly fused with a corresponding ct dataset fusion results will be incorrectly loaded into fastplan's cone planning if an empty series date data field is encountered. no warning or error message is produced. any resulting large misalignment should be obvious if the blended ct-mr view is selected since the isocenter will be misplaced on the 3d view and trace contour views. in the worst case scenario however if you use the default mr- only view settings perform planning on mr only and do not notice isocenter misplacement on the 3d view or on contour tracing slides this could lead to a significant mis-alignment of the plan.

Device

OPTICAL GUIDANCE PLATFORM - FASTPLAN SYSTEM
  • Modèle / numéro de série
    Model Catalog: 9701505A (Lot serial: PCSN: HZ37010)
  • Description du dispositif
    OPTICAL GUIDANCE PLATFORM - FASTPLAN SYSTEM
  • Manufacturer
    VARIAN MEDICAL SYSTEMS INC.

Manufacturer

VARIAN MEDICAL SYSTEMS INC.