Events

Retiro De Equipo (Recall) de EFILM WORKSTATION

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por MERGE HEALTHCARE INCORPORATED.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    53353
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2014-09-19
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    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.
  • Notas adicionales en la data
  • Causa
    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
  • Modelo / Serial
    Model Catalog: EFILM01 (Lot serial: N/A)
  • Descripción del producto
    EFILM WORKSTATION 4.0 AND EFILM WORKSTATION 4.0.1
  • Manufacturer
    MERGE HEALTHCARE INCORPORATED

Manufacturer

MERGE HEALTHCARE INCORPORATED