Events

Rappel de CENTRICITY UNIVERSAL VIEWER - MAIN UNIT

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par GE HEALTHCARE CANADA 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
    130524
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2018-02-06
  • 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 following issue is being addressed by ge healthcare file no. fmi 85442. ge healthcare has recently become aware that a database handling error could occur during the image acquisition process affecting the completeness of acquired images with centricity universal viewer running on a pacs-iw foundation. there is a potential that one or more "image series" (i.E. all images within an image set) may be missing from an exam without a user warning displayed in the viewer. while this is rare this can occur with imaging studies that consist of a very small number of images per series. e.G. cr thorax exam with 1 image per series. there have been no injuries reported as a result of this issue.

Device

CENTRICITY UNIVERSAL VIEWER - MAIN UNIT
  • Modèle / numéro de série
    Model Catalog: 2088034-X (Lot serial: GTIN 00840682103800)
  • Description du dispositif
    CENTRICITY UNIVERSAL VIEWER - MAIN UNIT
  • Manufacturer
    GE HEALTHCARE CANADA INC.

Manufacturer

GE HEALTHCARE CANADA INC.