Events

Rappel de VITREA ADVANCED SOFTWARE DVD

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par TOSHIBA CANADA MEDICAL SYSTEMS LIMITED.

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
    37033
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2013-03-28
  • 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
    Field correction based on a product labelling deficiency. potential user confusion when viewing a brain perfusion scan on vitrea ct brain perfusion 2d when the scan was performed using a wide coverage shuttle acquisition technique. user confusion may result in patient treatment delays misdiagnosis or mistreatment.

Device

VITREA ADVANCED SOFTWARE DVD
  • Modèle / numéro de série
    Model Catalog: VPMC-12393 (Lot serial: VERSION 5.2 AND EARLIER); Model Catalog: VPMC-12252 (Lot serial: VERSION 5.2 AND EARLIER); Model Catalog: VPMC-12324 (Lot serial: VERSION 5.2 AND EARLIER); Model Catalog: VPMC-12395 (Lot serial: VERSION 5.2 AND EARLIER); Model Catalog: VPMC-12508 (Lot serial: VERSION 5.2 AND EARLIER); Model Catalog: VPMC-12190 (Lot serial: VERSION 5.2 AND EARLIER); Model Catalog: VPMC-12253 (Lot serial: VERSION 5.2 AND EARLIER); Model Catalog: VPMC-12325 (Lot serial: VERSION 5.2 AND EARLIER); Model Catalog: VPMC-12396 (Lot serial: VERSION 5.2 AND EARLIER); Model Catalog: VPMC-12509 (Lot serial: VERSION 5.2 AND EARLIER); Model Catalog: VPMC-12193 (Lot serial: VERSION 5.2 AND EARLIER); Model Catalog: VPMC-12254 (Lot serial: VERSION 5.2 AND EARLIER); Model Catalog: VPMC-12506 (Lot serial: VERSION 5.2 AND EARLIER); Model Catalog: VPMC-12189 (Lot serial: VERSION 5.2 AND EARLIER); Model Catalog: VPMC-12322 (Lot serial: VERSION 5.2 AND EARLIER); Model Catalog: VPMC-12021 (Lot serial: VERSION 5
  • Description du dispositif
    VITREA ADVANCED SOFTWARE DVD
  • Manufacturer
    TOSHIBA CANADA MEDICAL SYSTEMS LIMITED

Manufacturer

TOSHIBA CANADA MEDICAL SYSTEMS LIMITED
  • Adresse du fabricant
    MARKHAM
  • Société-mère du fabricant (2017)
    Canon Inc
  • Source
    HC