Events

Retiro De Equipo (Recall) de AW SERVER

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE).

¿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
    86954
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2011-11-03
  • 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
    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)