Events

Retiro De Equipo (Recall) de AQUILION ONE 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 CANON MEDICAL SYSTEMS CANADA LIMITED.

¿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
    26441
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2013-09-09
  • 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
    In some aquilion one and aquilion prime ct scanners with certain software version due to a problem of the x-ray output control software the x-ray output conditions cannot be set correctly in some cases. as a result occasionally the x-ray exposure under the scan conditions used for contrast study may not start.

Device

AQUILION ONE SYSTEM - MAIN UNIT
  • Modelo / Serial
    Model Catalog: TSX-301A_/2C (Lot serial: SERIAL: 2KC1172339); Model Catalog: TSX-301A_/2C (Lot serial: SERIAL: 2CC1122287); Model Catalog: TSX-301A_/2C (Lot serial: SERIAL: 2CC10X2243); Model Catalog: TSX-301A_/2C (Lot serial: SERIAL: 2CA1062201); Model Catalog: TSX-301A_/2C (Lot serial: SERIAL: 2CA09Y2156); Model Catalog: TSX-301A_/2C (Lot serial: SERIAL: 2CA0982130); Model Catalog: TSX-301A_/2C (Lot serial: SERIAL: 2CA0872039); Model Catalog: TSX-301A_/2C (Lot serial: SERIAL: 2CA0862035); Model Catalog: TSX-301A_/2C (Lot serial: SERIAL: 2CA0852030); Model Catalog: TSX-301A_/2C (Lot serial: SERIAL: 2CA0852028); Model Catalog: TSX-301A_/2C (Lot serial: SERIAL: 2CA0842022); Model Catalog: TSX-301A_/2C (Lot serial: SERIAL: 2CA0822017); Model Catalog: TSX-301A_/2C (Lot serial: SERIAL: 2CA07X2007); Model Catalog: TSX-301A_/2C (Lot serial: SERIAL: 2CA0972125); Model Catalog: TSX-301A_/2C (Lot serial: SERIAL: 2CA0912100); Model Catalog: TSX-301A_/2C (Lot serial: SERIAL: 2CA08Y2079); Model Catalog: TSX-301A_/2C (Lo
  • Descripción del producto
    AQUILION ONE SYSTEM - MAIN UNIT
  • Manufacturer
    CANON MEDICAL SYSTEMS CANADA LIMITED

Manufacturer

CANON MEDICAL SYSTEMS CANADA LIMITED
  • Dirección del fabricante
    MARKHAM
  • Empresa matriz del fabricante (2017)
    Canon Inc
  • Source
    HC