Events

Rappel de OMNYX INTEGRATED DIGITAL PATHOLOGY SYSTEM - ROUTINE PATHOLOGY APPLICATION

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
    31577
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2015-11-20
  • 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
    During internal evaluations omnyx became aware that variations in immunohistochemically (ihc) stained slide images may result from slides scanned with a limited number of idp vl120 scanners. further investigation determined that the installed scanner may have been manufactured with an out-of-specification led assembly. there have been no reported adverse events associated with this issue.

Device

OMNYX INTEGRATED DIGITAL PATHOLOGY SYSTEM - ROUTINE PATHOLOGY APPLICATION
  • Modèle / numéro de série
    Model Catalog: OMN-10005072-X (Lot serial: DSAT00103); Model Catalog: OMN-10005072-X (Lot serial: DSAT00104); Model Catalog: OMN-10005072-X (Lot serial: DSAT00105); Model Catalog: OMN-10005072-X (Lot serial: DSAT00111)
  • Description du dispositif
    Omnyx Integrated Digital Pathology System VL120 Scanner IVD
  • Manufacturer
    GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)