Retiro De Equipo (Recall) de 1.5T SIGNA HDX MR 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
    153402
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2010-10-15
  • País del evento
  • 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
    If gradient cables are inadvertently swapped while servicing and geometry check not performed as required in procedure images may be flipped left-right with incorrect orientation annotation.

Device

  • Modelo / Serial
    Model Catalog: M3335JG (Lot serial: ALL SERIAL NUMBERS); Model Catalog: M3335J (Lot serial: ALL SERIAL NUMBERS); Model Catalog: M3335JA (Lot serial: ALL SERIAL NUMBERS); Model Catalog: M3000TD (Lot serial: ALL SERIAL NUMBERS); Model Catalog: M1800MA (Lot serial: ALL SERIAL NUMBERS); Model Catalog: SIGNA HDXT 1.5T MR SYSTEM (Lot serial: ALL SERIAL NUMBERS); Model Catalog: M3333TD (Lot serial: ALL SERIAL NUMBERS); Model Catalog: M1060YW (Lot serial: ALL SERIAL NUMBERS); Model Catalog: M1060LG (Lot serial: ALL SERIAL NUMBERS); Model Catalog: M1000RA/RD/RF/RG (Lot serial: ALL SERIAL NUMBERS); Model Catalog: DISCOVERY MR450 1.5T MR SYSTEM (Lot serial: ALL SERIAL NUMBERS); Model Catalog: M3335JK (Lot serial: ALL SERIAL NUMBERS); Model Catalog: M1000MA (Lot serial: ALL SERIAL NUMBERS); Model Catalog: M7000MC (Lot serial: ALL SERIAL NUMBERS); Model Catalog: S7504HP (Lot serial: ALL SERIAL NUMBERS); Model Catalog: M7000MA (Lot serial: ALL SERIAL NUMBERS)
  • Descripción del producto
    1.5T SIGNA HDX MR SYSTEM - MAIN UNIT
  • Manufacturer

Manufacturer