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
    33076
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2016-06-08
  • 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
    A small area on the bore surface which is normally accessible to the patient can get warm enough to cause a serious burn in the event the patient touches the bore and proper padding is not used. no injury has been reported to ge as a result of this issue. this issue has been observed only in the rare situation in which a user has routinely used the system for off center imaging with large patients (for example off center wrist or shoulder exams) with transmit gain set near maximum levels.

Device

DISCOVERY MR750W 3.0T MAGNETIC RESONANCE IMAGING SYSTEM - MAIN UNIT

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)