Events

Retiro De Equipo (Recall) de AW VOLUMESHARE 4 - SENO ADVANTAGE SOFTWARE OPTION

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
    144607
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2012-09-13
  • 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
    Ge healthcare has become aware that patient mismatch without a warning message could occur on seno advantage (sa) workstations under the following circumstances: 1. new non-mammographic images for patient a are being received (for example via the network) at the same time that mammographic images for patient a are displayed on the high-resolution black and white monitors. 2. the non-mammographic images are then selected and displayed on the color monitor. 3. mammographic images from a different patient are then selected on the high-resolution black and white monitors.

Device

AW VOLUMESHARE 4 - SENO ADVANTAGE SOFTWARE OPTION
  • Modelo / Serial
    Model Catalog: 5341143-X (Lot serial: 000004410002GS); Model Catalog: 5183685-X (Lot serial: >10 lot numbers contact mfg); Model Catalog: 5183859-X (Lot serial: >10 lot numbers contact mfg); Model Catalog: 5342425-X (Lot serial: 00000193277GE1)
  • Descripción del producto
    AW VOLUMESHARE - SENO ADVANTAGE SOFTWARE OPTION
  • Manufacturer
    GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)