Events

Rappel de SEGMENTED CYLINDER SET

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
    127918
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2011-08-04
  • 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
    In the previous recall (55250) the blocking washer on the flexible probe (gm11002420) may shift and users are not to use a flexible probe with an unstable or shifted blocking washer due to potential for treatment error. this update notice supplements and modifies the previous instructions that you may continue to use the original design flexible probe with blocking washer and old design guiding tube. here users are instructed to stop using these older products (gm11002420 flexible applicabtor probe with blocking washer at 234 mm (old design) gm11005170 guiding tube for segmented cylinders (old design). this update notice request requires that users return these original design products to varian brachytherapy for replacement with the updated designs for them free of charge.

Device

SEGMENTED CYLINDER SET
  • Modèle / numéro de série
    Model Catalog: GM11004150 (Lot serial: >10 Serial numbers.); Model Catalog: GM11004150 (Lot serial: Contact manufacturer.)
  • Description du dispositif
    SEGMENTED CYLINDER SET
  • Manufacturer
    VARIAN MEDICAL SYSTEMS INC.

Manufacturer

VARIAN MEDICAL SYSTEMS INC.