Events

Rappel de EFILM WORKSTATION

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par MERGE HEALTHCARE INCORPORATED.

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
    53353
  • Classe de risque de l'événement
    III
  • Date de mise en oeuvre de l'événement
    2014-09-19
  • 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
    On august 11 2014 a customer in another country reported that when working with multiple studies and using thumbnail panels (i.E. using a very specific workflow) the thumbnail tab changed unexpectedly. the radiologist noticed a flicker on the screen and checked the dicom study information displayed on the image. he realized that it was not the study that he had intended to add to the viewport and thus avoided dictating a report based on the wrong study. no patients were affected. upon investigation a problem was discovered where the efilm workstation software may cause the user interface for the thumbnail panel tabs to refresh and to switch tabs. if the user does not notice this it may result in the selection of a different series than the one the user intended to add (by dragging thumbnails down from the thumbnail panel) to the viewing panes in the main screen. additionally when tabs are switched selected image highlighting in the thumbnail panel may incorrectly highlight a series that does not match the series in the viewport. note that the user must look at the date on the image to confirm that the correct image series or study is being reviewed. the date information on the images is correct and is not affected by this problem.

Device

EFILM WORKSTATION
  • Modèle / numéro de série
    Model Catalog: EFILM01 (Lot serial: N/A)
  • Description du dispositif
    EFILM WORKSTATION 4.0 AND EFILM WORKSTATION 4.0.1
  • Manufacturer
    MERGE HEALTHCARE INCORPORATED

Manufacturer

MERGE HEALTHCARE INCORPORATED