Rappel de CENTRICITY DMS SOFTWARE VERSIONS 4.X

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
    20668
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2010-03-03
  • Pays de l'événement
  • 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
    If user inputs free text into the notes node & the free text exceeds 2000 characters and if user clicks the close button before they click the confirm 1 button the text may not be saved & user will not be warned & the text may be permanently lost.

Device

  • Modèle / numéro de série
    Model Catalog: P0002MD (Lot serial: P0001ME P0002MD & P0002ME); Model Catalog: P0001ME (Lot serial: P0001ME P0002MD & P0002ME); Model Catalog: P0001MD (Lot serial: P0001ME P0002MD & P0002ME); Model Catalog: P0002NY (Lot serial: P0001ME P0002MD & P0002ME); Model Catalog: P0001NY (Lot serial: P0001NY P0002NY P0001MD); Model Catalog: P0002ME (Lot serial: P0001NY P0002NY P0001MD); Model Catalog: P0002MD (Lot serial: P0001NY P0002NY P0001MD); Model Catalog: P0001ME (Lot serial: P0001NY P0002NY P0001MD); Model Catalog: P0001MD (Lot serial: P0001NY P0002NY P0001MD); Model Catalog: P0002NY (Lot serial: P0001NY P0002NY P0001MD); Model Catalog: P0002ME (Lot serial: P0001ME P0002MD & P0002ME); Model Catalog: P0001NY (Lot serial: P0001ME P0002MD & P0002ME)
  • Description du dispositif
    CENTRICITY DMS SOFTWARE VERSIONS 4.X
  • Manufacturer

Manufacturer