Events

Retiro De Equipo (Recall) de SIGNA CREATOR

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
    133205
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2016-08-23
  • 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 following issue is being addressed by ge healthcare file no. fmi 67921: ge healthcare has become aware of an issue involving two power monitor failures. these two failures together could result in higher than expected thermal dose to the patient and higher than expected localized heating. there have been no failures of this type reported and no injuries reported as a result of this issue.

Device

SIGNA CREATOR

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)