Events

Retiro De Equipo (Recall) de REVOLUTION CT - 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
    75441
  • Clase de Riesgo del Evento
    III
  • 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. 25470. the revolution ct exceeds iec conducted emission requirements. during recent certification testing ge healthcare determined that one configuration of the revolution ct product exceeds the conducted emissions limits specified in the iec60601-1-2:2007 emc standard. medical devices powered on the same power line as the revolution ct power distribution unit (pdu) may be affected by electrical emissions through the power line. equipment powered from the ct system such as the ekg monitor or patient contrast injector are not affected.

Device

REVOLUTION CT - MAIN UNIT

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)