Events

Retiro De Equipo (Recall) de AQUILION 64 SYSTEM

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
    153729
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2011-05-27
  • 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 the aquilion system the following software issues have been noted (1)the confirmation may not be displayed properly during scanoscopy (2)if the pgp hard split option is used and the scano skip button is pressed the second scanoscopy may not be completed (3)the use of pgp hard split may result in an error in image display processing (4)if more than 10 characters is entered in the image comment the system software will terminate abnormally. (5) under certain circumstances if the helical skip button is clicked during one of the scanning the next helical scan may stop before it is completed.

Device

AQUILION 64 SYSTEM
  • Modelo / Serial
    Model Catalog: TSX-101A/H (Lot serial: S/N: HCB1083821); Model Catalog: TSX-101A/H (Lot serial: S/N: HCB10X3839); Model Catalog: TSX-101A/H (Lot serial: S/N: HCB1083820); Model Catalog: TSX-101A/H (Lot serial: S/N: HCB1023750)
  • Descripción del producto
    AQUILION 64
  • 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