Events

Rappel de CLINAC IX HIGH ENERGY LINEAR ACCELERATOR

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
    95992
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2013-04-23
  • 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
    Under certain conditions photon beams in high energy clinacs may experience a gradual change in beam symmetry potentially reaching an asymmetry of up to approximately 7 % before interlock occurs. at maximum asymmetry this may result in no more than approximately 3.5% dose deviation from expected at any point in the beam. the type of asymmetry normally results in a beam which is higher than desired on one side of the central axis lower on the other side and approximately correct at the central axis. asymmetry value as used here means the peak to peak (over to under) differences observed. therefore a maximum asymmetry of 7% will result in a dose deviation of no more than 3.5% at any point in the beam with a smaller deviation near the central axis of the beam. normally the central axis dose values represent the calibration point and are not affected.

Device

CLINAC IX HIGH ENERGY LINEAR ACCELERATOR
  • Modèle / numéro de série
    Model Catalog: CLINAC IX (Lot serial: >10 serial numbers.); Model Catalog: CLINAC IX (Lot serial: contact manufacturer.); Model Catalog: 21EX (Lot serial: contact manufacturer.); Model Catalog: 21EX (Lot serial: >10 serial numbers.); Model Catalog: TRILOGY (Lot serial: H294991); Model Catalog: 2100C (Lot serial: H272118); Model Catalog: TRILOGY (Lot serial: H294551); Model Catalog: TRILOGY (Lot serial: H293787); Model Catalog: TRILOGY (Lot serial: H140836); Model Catalog: TRILOGY (Lot serial: H291172); Model Catalog: TRILOGY (Lot serial: H294934); Model Catalog: TRILOGY (Lot serial: H294750); Model Catalog: TRILOGY (Lot serial: H294403); Model Catalog: 2100C (Lot serial: H270838); Model Catalog: 2100C (Lot serial: H270544); Model Catalog: 2100C (Lot serial: H270823); Model Catalog: 2100C (Lot serial: H271161); Model Catalog: 2100C (Lot serial: H270708); Model Catalog: TRILOGY (Lot serial: H291166)
  • Description du dispositif
    Clinac IX High Energy Linear Accelerator
  • Manufacturer
    VARIAN MEDICAL SYSTEMS INC.

Manufacturer

VARIAN MEDICAL SYSTEMS INC.