Events

Rappel de CENTRICITY PACS WORKSTATION - HARDWARE

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
    22491
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2008-11-07
  • 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
    1)a forced log off may occur during an open session 2)centricity enterprise web does not utilize calibration performed on image measurements in centricity ra1000 workstation.

Device

CENTRICITY PACS WORKSTATION - HARDWARE
  • Modèle / numéro de série
    Model Catalog: P0001L (Lot serial: 519646AIMB 519685TESTAIM); Model Catalog: K2080PN (Lot serial: 519646AIMB 519685TESTAIM); Model Catalog: K2033KK (Lot serial: 519646AIMB 519685TESTAIM); Model Catalog: P0001L (Lot serial: 416360CVPACS 519685AIMA); Model Catalog: K2033KK (Lot serial: S/N'S USE835NAJK 905895DIEA); Model Catalog: K2033KK (Lot serial: 416360CVPACS 519685AIMA); Model Catalog: P0001L (Lot serial: S/N'S USE835NAJK 905895DIEA); Model Catalog: K2080PN (Lot serial: S/N'S USE835NAJK 905895DIEA); Model Catalog: K2080PN (Lot serial: 416360CVPACS 519685AIMA); Model Catalog: P0001KA (Lot serial: s/n USE824N5BV 905895DIEA); Model Catalog: P0001KA (Lot serial: 416360CVPACS); Model Catalog: K2033KL (Lot serial: 416360CVPACS); Model Catalog: P0001KC (Lot serial: 416360CVPACS); Model Catalog: K2033KL (Lot serial: s/n USE824N5BV 905895DIEA); Model Catalog: P0001KC (Lot serial: s/n USE824N5BV 905895DIEA); Model Catalog: K2034JP (Lot serial: >10 NUMBERS); Model Catalog: K2034JP (Lot serial: CONTACT); Model Catalo
  • Description du dispositif
    CENTRICITY PACS WORKSTATION - HARDWARE
  • Manufacturer
    GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)