Events

Rappel de ON-BOARD IMAGER

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
    131793
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2011-06-30
  • 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 in the 3d match environment of obi 1.3 obi 1.4 obi 1.5 truebeam 1.0 and offline review 1.0 - 2.0 when using reference ct datasets which contain a critical number of slices. [note that the 3d match environments of truebeam 1.5 and offline review 2.1 are not affected by this anomaly.] when these reference ct datasets are used to create a reference ct volume in the 3d match environment in a small number of cases the scaling of the ct volume will be incorrect and the ct volume will appear larger - in the slice direction - than it actually should be. if this improperly scaled ct volume is used for 3d matching the cbct volume and patient may be positioned too far superiorly. because of differences in software design obi 1.5 is much more likely to exhibit this behavior than the other products identified.

Device

ON-BOARD IMAGER
  • Modèle / numéro de série
    Model Catalog: OBI (Lot serial: Contact manufacturer.); Model Catalog: TRUEBEAM (Lot serial: H191038); Model Catalog: OBI (Lot serial: >10 serial numbers.); Model Catalog: TRUEBEAM (Lot serial: H191071); Model Catalog: TRUEBEAM (Lot serial: H191044); Model Catalog: TRUEBEAM (Lot serial: H191069)
  • Description du dispositif
    On Board Imager
  • Manufacturer
    VARIAN MEDICAL SYSTEMS INC.

Manufacturer

VARIAN MEDICAL SYSTEMS INC.