Events

Rappel de TRUEBEAM (RADIOTHERAPY CONFIGURATION) - MAIN UNIT

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
    105845
  • 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
    The 4ditc ad-hoc imaging ciao (complete irradiated area outline) calculation results in a ciao shape that differs from the ciao calculated in ariachart eclipse offline review and on-board imager. the 4ditc algorithm adds dose for the control point at the field edge which should not be added according to the system specifications. this error will be present in the 4ditc mlc display. the discrepancy is a display issue that is only seen when an ad-hoc image template has been added after the plan has been loaded on the 4ditc. if the 4ditc generated ciao image is projected on the patient using the light field the incorrect field edge will be displayed. if the field edge is used to set-up another abutting treatment field the area between the projected field edge and the abutting field edge would be mismatched and not treated.

Device

TRUEBEAM (RADIOTHERAPY CONFIGURATION) - MAIN UNIT
  • Modèle / numéro de série
    Model Catalog: TRUEBEAM (Lot serial: H191044); Model Catalog: TRUEBEAM (Lot serial: H191069); Model Catalog: TRUEBEAM (Lot serial: H191071); Model Catalog: TRUEBEAM (Lot serial: H191038); Model Catalog: TRUEBEAM (Lot serial: H191074); Model Catalog: V8.8 (Lot serial: CONTACT MANUFACTURER.); Model Catalog: V8.6 (Lot serial: >10 SERIAL NUMBERS.); Model Catalog: V8.8 (Lot serial: >10 SERIAL NUMBERS.); Model Catalog: V8.6 (Lot serial: CONTACT MANUFACTURER.); Model Catalog: V8.1.2 (Lot serial: CONTACT MANUFACTURER.); Model Catalog: V8.1.2 (Lot serial: >10 SERIAL NUMBERS.)
  • Description du dispositif
    TRUEBEAM (RADIOTHERAPY CONFIGURATION) - MAIN UNIT
  • Manufacturer
    VARIAN MEDICAL SYSTEMS INC.

Manufacturer

VARIAN MEDICAL SYSTEMS INC.