Events

Retiro De Equipo (Recall) de Device Recall Digital Radiography System with Flat Panel Detector

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Toshiba American Med Sys Inc.

¿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
    45567
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0293-2008
  • Fecha de inicio del evento
    2007-10-01
  • Fecha de publicación del evento
    2007-11-27
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-04-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=65789
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Angiography System - Product Code MQB
  • Causa
    System lock-up: when performing das one shot, the system may lockup due to a software timing error.
  • Acción
    Notification letters (Urgent: Medical Device Correction-dated October 1, 2007) with an attached Customer Response form were sent to customers beginning on October 2, 2007. Customers were notified this action was being taken as a result of an investigation that resulted from a software issue that was found done by the manufacturer. Customers were informed that a Toshiba Customer Service Engineer would contact them to schedule a software upgrade when the software becomes available. If customers have any questions they were instructed to contact their or call (800) 421-1968 and ask for the Regulatory Affairs Department.

Device

Device Recall Digital Radiography System with Flat Panel Detector
  • Modelo / Serial
    Serial numbers: B5522165, W1C0562187, W1C0572197, W1C0572202, W1C0622275, W1C0622270, A3632065, A3622066, W1C0456192, W1C0632284, W1D0722373, W1D0742386, B5512160, W1C0592213, W1C0592215, A4562099, W1C05Z2254, B4582113, W1C0642289, W1D0697015, W1C0552182, W1C05X2224, W1D0742387
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide-including states of AL, AR, FL, GA, MI, NY, OH, PA, TX & WV
  • Descripción del producto
    Toshiba-Interventional Angiography System, Infinix i, Model DFP-8000D, equiped with Digital Radiography System with Software version 3.4er000, Toshiba America Medical Systems, Inc., Tustine, CA 92780
  • Manufacturer
    Toshiba American Med Sys Inc

Manufacturer

Toshiba American Med Sys Inc
  • Dirección del fabricante
    Toshiba American Med Sys Inc, 2441 Michelle Dr, P.O. Box 2068, Tustin CA 92781-2068
  • Source
    USFDA