Events

Rappel de AW SERVER

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
    86954
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2011-11-03
  • 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
    Issue #1 (volume viewer): on monitors with 2 megapixel (2mp) resolution and higher (i.E. higher than 1600x1200 resolution) for a certain sequence of user commands switching between two volume viewer tabs with different patients the topmost strip of the volume viewer display fails to update between patients. this causes the incorrect (i.E. first) patient name to display in the topmost viewports when the second patient's image data is displayed. the lower viewports display the correct patient name as does the patient name tab. issue #2 (results viewer): on aw server the results viewer application may take 5-8 seconds to initialize and display a selected patient exam when first started. if a second patient exam is selected before this initialization has completed the second patient's data will be displayed in the viewports with the corresponding patient name on the viewports. however the first patient's name will be displayed on the applications tab.

Device

AW SERVER

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)