Events

Retiro De Equipo (Recall) de 1.5T SIGNA INFINITY TWINSPEED WITH EXCITE

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
    24038
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2009-09-09
  • 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
    Use of cadstream with "pure" software for dynamic mri imaging may require a modification to the study preference settings to present colour overlays equivalent to non-pure studies.

Device

1.5T SIGNA INFINITY TWINSPEED WITH EXCITE
  • Modelo / Serial
    Model Catalog: M3000TD (Lot serial: MANUFACTURER); Model Catalog: M3000TD (Lot serial: >10 NUMBERS); Model Catalog: M3000TD (Lot serial: CONTACT); Model Catalog: M3000LF (Lot serial: 274168MR4 270572MR1); Model Catalog: M7000BF (Lot serial: S/N'S 291192MR3 290992MR7); Model Catalog: M3000LF (Lot serial: S/N'S HDMR10368 7547YR3); Model Catalog: M3000LF (Lot serial: 278606MR9 266072MR8); Model Catalog: 2294302 (Lot serial: 253630MR8 239043MR3); Model Catalog: 2294302 (Lot serial: S/N'S 243409MR0 239046MR6); Model Catalog: 2294302 (Lot serial: 256216MR3 246610MR0); Model Catalog: 2294302 (Lot serial: 258415MR9 247728MR9); Model Catalog: 2294302 (Lot serial: 242181MR6); Model Catalog: SIGNA HDXT 1.5T MR SYSTEM (Lot serial: S/N 30BD4960); Model Catalog: M3333TA (Lot serial: S/N'S 6690YR2 266690MR7); Model Catalog: M3335PB (Lot serial: >10 NUMBERS); Model Catalog: M3335PB (Lot serial: CONTACT); Model Catalog: M3335PB (Lot serial: MANUFACTURER); Model Catalog: M3335JK (Lot serial: S/N 7555YR6)
  • Descripción del producto
    1.5T SIGNA INFINITY TWINSPEED EXCITE
  • Manufacturer
    GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)