Events

Rappel de RAYSTATION

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par RAYSEARCH LABORATORIES AB (PUBL).

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
    146386
  • Classe de risque de l'événement
    III
  • Date de mise en oeuvre de l'événement
    2016-09-12
  • 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
    When an roi with material override overlaps a fixation or support roi the material used for dose calculation in the overlapping region may not be as intended. also when a support or fixation roi overlaps the patient outline (external roi) in a dose grid voxel along the outer surface of the patient outline the density used for dose calculation in that voxel may not be as intended.

Device

RAYSTATION
  • Modèle / numéro de série
    Model Catalog: 2.5 (Lot serial: 4.7.1.10); Model Catalog: 4.7 (Lot serial: 4.7.0.15); Model Catalog: 4.5 (Lot serial: 4.7.0.15); Model Catalog: 4.0 (Lot serial: 4.7.0.15); Model Catalog: 3.0 (Lot serial: 4.7.0.15); Model Catalog: 2.5 (Lot serial: 4.7.0.15); Model Catalog: 4.7 (Lot serial: 4.5.2.7); Model Catalog: 4.5 (Lot serial: 4.5.2.7); Model Catalog: 4.0 (Lot serial: 4.5.2.7); Model Catalog: 3.0 (Lot serial: 4.5.2.7); Model Catalog: 2.5 (Lot serial: 4.5.2.7); Model Catalog: 4.7 (Lot serial: 4.5.1.14); Model Catalog: 4.5 (Lot serial: 4.5.1.14); Model Catalog: 4.0 (Lot serial: 4.5.1.14); Model Catalog: 3.0 (Lot serial: 4.5.1.14); Model Catalog: 2.5 (Lot serial: 4.5.1.14); Model Catalog: 4.7 (Lot serial: 4.5.0.19); Model Catalog: 4.5 (Lot serial: 4.5.0.19); Model Catalog: 4.0 (Lot serial: 4.5.0.19); Model Catalog: 3.0 (Lot serial: 4.5.0.19); Model Catalog: 2.5 (Lot serial: 4.5.0.19); Model Catalog: 4.7 (Lot serial: 4.0.3.4); Model Catalog: 4.5 (Lot serial: 4.0.3.4); Model Catalog: 4.0 (Lot serial: 4.0.3.4);
  • Description du dispositif
    RAYSTATION
  • Manufacturer
    RAYSEARCH LABORATORIES AB (PUBL)

Manufacturer

RAYSEARCH LABORATORIES AB (PUBL)