Events

Retiro De Equipo (Recall) de X-RAY HIGH-VOLTAGE GENERATOR

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por TOSHIBA CANADA MEDICAL SYSTEMS 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
    107210
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2013-08-02
  • 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
    It has been found that when radiographic conditions with the small focus are set and the radiography ready switch is held down the large focus is also heated after a few seconds or more. as a result a radiographic tube current exceeding the set value flows and a brighter image than expected is acquired when the aec (automatic exposure control) function is not used.

Device

X-RAY HIGH-VOLTAGE GENERATOR
  • Modelo / Serial
    Model Catalog: KXO-80XD (Lot serial: S/N: 99A0542035X); Model Catalog: KXO-80XM/J1 (Lot serial: S/N: J1H0933456); Model Catalog: KXO-80XM (Lot serial: S/N: J1H0933456); Model Catalog: KXO-80XM (Lot serial: S/N: F3532527); Model Catalog: KXO-80XM (Lot serial: S/N: J1H0713302); Model Catalog: KXO-80XM/J1 (Lot serial: S/N: J1G0653183); Model Catalog: KXO-80XM (Lot serial: S/N: J1G0653183); Model Catalog: KXO-80XM/J1 (Lot serial: S/N: F3532527); Model Catalog: KXO-80XD (Lot serial: S/N: 99C1192362); Model Catalog: KXO-80XM/J1 (Lot serial: S/N: J1H0713302)
  • Descripción del producto
    X-RAY HIGH-VOLTAGE GENERATOR
  • Manufacturer
    TOSHIBA CANADA MEDICAL SYSTEMS LIMITED

Manufacturer

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