Events

Rappel de VARIAN TREATMENT FOR MULTIVENDOR LINACS

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
    86885
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2012-05-03
  • 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
    An anomaly has been identified with varian treatment apploication failing to load a physical wedge filter for a treatment field delivered on a siemens mevatron linear accelerator. after a plan with wedge field is opened on varian treatment users may not observe that a wedge filter may actually be missing from one or more fields without any notification from the treatment application. the user may come to understand that the wedge filter was missing only after the treatment field had been partially or completely delivered. when the user attempts to close the patient session from the treatment application. in this situation the treatment application forces the user to unload the patient session requires user authorization and informs the user that the treatment record for the missing wedge field(s) cannot be saved to varian's oncology information system (ois). delivery of a treatment field without the planned wedge filter could result in an over dosage for that beam and potentially an unintended dose uniformity of the target treatment volume. this anomaly is intermittent and may occur infrequently. this issue could occur with a siemens elekta or ge system that has physical wedges.

Device

VARIAN TREATMENT FOR MULTIVENDOR LINACS
  • Modèle / numéro de série
    Model Catalog: 100042022 (Lot serial: H466051); Model Catalog: 100042022 (Lot serial: H466052); Model Catalog: 100042022 (Lot serial: H466053); Model Catalog: 100042022 (Lot serial: H466050); Model Catalog: 100042022 (Lot serial: H462051); Model Catalog: 100042022 (Lot serial: H462050)
  • Description du dispositif
    Varian Treatment For Multivendor Linacs
  • Manufacturer
    VARIAN MEDICAL SYSTEMS INC.

Manufacturer

VARIAN MEDICAL SYSTEMS INC.