Events

Rappel de MULTILEAF COLLIMATOR

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
    47235
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2012-05-16
  • 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
    Failure to retract or park the varian mlc leaves prior to use of the demountable brainlab m3 could result in the varian mlc leaves interfering with treatment field defined by brainlab m3 without an interlock being asserted. when a demountable brainlab m3 mlc is installed on a varian accelerator the use of two a-b switches is required to deploy the desired mlc. both switches must be set to the correct position prior to use. the first a-b switch box connects the mlc workstation to either the varian mlc controller or to the brainlab m3 controller. the second a-b switch box connects the clinac console to either the varian mlc controller or the brainlab m3 controller. this connection includes the mlc interlock used to inhibit radiation from the clinac accelerator. the mlc that is not selected on this a-b switch is disconnected from the interlock circuitry.

Device

MULTILEAF COLLIMATOR
  • Modèle / numéro de série
    Model Catalog: MLC 52 (Lot serial: H520320); Model Catalog: MILLENIUM 80 (Lot serial: H542533); Model Catalog: MLC 52 (Lot serial: H542533); Model Catalog: MILLENIUM 80 (Lot serial: H520320); Model Catalog: MILLENIUM 80 (Lot serial: H542182); Model Catalog: MLC 52 (Lot serial: H542182)
  • Description du dispositif
    MULTILEAF COLLIMATOR
  • Manufacturer
    VARIAN MEDICAL SYSTEMS INC.

Manufacturer

VARIAN MEDICAL SYSTEMS INC.