Events

Retiro De Equipo (Recall) de VITREA ADVANCED SOFTWARE DVD

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
    37033
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2013-03-28
  • 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
    Field correction based on a product labelling deficiency. potential user confusion when viewing a brain perfusion scan on vitrea ct brain perfusion 2d when the scan was performed using a wide coverage shuttle acquisition technique. user confusion may result in patient treatment delays misdiagnosis or mistreatment.

Device

VITREA ADVANCED SOFTWARE DVD
  • Modelo / Serial
    Model Catalog: VPMC-12393 (Lot serial: VERSION 5.2 AND EARLIER); Model Catalog: VPMC-12252 (Lot serial: VERSION 5.2 AND EARLIER); Model Catalog: VPMC-12324 (Lot serial: VERSION 5.2 AND EARLIER); Model Catalog: VPMC-12395 (Lot serial: VERSION 5.2 AND EARLIER); Model Catalog: VPMC-12508 (Lot serial: VERSION 5.2 AND EARLIER); Model Catalog: VPMC-12190 (Lot serial: VERSION 5.2 AND EARLIER); Model Catalog: VPMC-12253 (Lot serial: VERSION 5.2 AND EARLIER); Model Catalog: VPMC-12325 (Lot serial: VERSION 5.2 AND EARLIER); Model Catalog: VPMC-12396 (Lot serial: VERSION 5.2 AND EARLIER); Model Catalog: VPMC-12509 (Lot serial: VERSION 5.2 AND EARLIER); Model Catalog: VPMC-12193 (Lot serial: VERSION 5.2 AND EARLIER); Model Catalog: VPMC-12254 (Lot serial: VERSION 5.2 AND EARLIER); Model Catalog: VPMC-12506 (Lot serial: VERSION 5.2 AND EARLIER); Model Catalog: VPMC-12189 (Lot serial: VERSION 5.2 AND EARLIER); Model Catalog: VPMC-12322 (Lot serial: VERSION 5.2 AND EARLIER); Model Catalog: VPMC-12021 (Lot serial: VERSION 5
  • Descripción del producto
    VITREA ADVANCED SOFTWARE DVD
  • 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