Events

Rappel de AW VOLUMESHARE 5 - VOLUME VIEWER OPTIONS

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE).

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
    58887
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2013-05-08
  • 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
    When using a customized pet vcar percist protocol with more than 1 target lesion selected for response calculation the software may compute an incorrect response percentage and/or criteria whereby the number of lesions used to calculate response on the prior study is different than the number of lesions used to calculate response on the follow-up study. in which case the response criteria generated under this condition will compare the sum of the target findings from the prior to the sum of findings on the follow-up study resulting in an incorrect response percentage. this error could lead to an incorrect response criteria categorization [i.E. a patient that is responding to treatment (partial metabolic response - pmr) could be categorized as not responding (stable metabolic disease - smd) or progressive (progressive metabolic disease - pmd).] miscategorization of this type could lead to changes in the course of patient treatment.

Device

AW VOLUMESHARE 5 - VOLUME VIEWER OPTIONS
  • Modèle / numéro de série
    Model Catalog: 5422769-X (Lot serial: 00000LA713783D); Model Catalog: 5422769-X (Lot serial: 00000L3A330899); Model Catalog: 5422769-X (Lot serial: 00000L3A87FE86); Model Catalog: 5422769-X (Lot serial: 00000L3A86843C); Model Catalog: 5422769-X (Lot serial: 00000L3A3305A1); Model Catalog: 5422769-X (Lot serial: 00000LA703D3E9); Model Catalog: 5422769-X (Lot serial: 00000LA7142C7C); Model Catalog: 5422769-X (Lot serial: 00000LA712A01B)
  • Description du dispositif
    PET VCAR
  • Manufacturer
    GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)