Events

Retiro De Equipo (Recall) de DISCOVERY MR750W 3.0T MAGNETIC RESONANCE IMAGING SYSTEM - MAIN UNIT

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
    28870
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2015-02-25
  • 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
    The latest on-site software version may not have been reinstalled at some sites after service activities were performed that required software to be reloaded. the most recently deployed on-site software version may include safety updates.

Device

DISCOVERY MR750W 3.0T MAGNETIC RESONANCE IMAGING SYSTEM - MAIN UNIT
  • Modelo / Serial
    Model Catalog: DISCOVERY MR750W 3.0T (Lot serial: 61377MR1); Model Catalog: DISCOVERY MR750W 3.0T (Lot serial: 416249MR2); Model Catalog: DISCOVERY MR750W 3.0T (Lot serial: 506648MR4); Model Catalog: S7505KY (Lot serial: 604941MR1 604520MR2); Model Catalog: S7505KY (Lot serial: 514341MRI 450688MR)
  • Descripción del producto
    DISCOVERY MR750W 3.0T MAGNETIC RESONANCE IMAGING
  • Manufacturer
    GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)