Retiro De Equipo (Recall) de Device Recall TSX301B: AQUILION Premium; System, XRay, Tomography, Computed

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 Medical Systems 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
    59690
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-3195-2011
  • Fecha de inicio del evento
    2011-06-22
  • Fecha de publicación del evento
    2011-09-13
  • Estado del evento
    Terminated
  • País del evento
  • Fecha de finalización del evento
    2014-08-11
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
  • 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
    System, x-ray, tomography, computed - Product Code JAK
  • Causa
    Toshiba america medical systems is initiating a field correction on their tsx-301b: aquilion premium; system, x-ray, tomography, computed, tsx-301a: aquilion one; system, x-ray, tomography, computed, tsx-20ia: aqulllon lb; system, x-ray, tomography, computed, and tsx-1o1a: aquilion 16; system, x-ray, tomography, computed due to several software issues that cause the scanners to function incorr.
  • Acción
    Toshiba America Medical Systems (TAMS) sent an URGENT MEDICAL DEVICE CORRECTION letter dated June 22, 2011, to all affected customers. Customers were instructed that a revised software to prevent occurrence of the problem would be installed on their system. Their Toshiba Service Representative would contact them for an appointment to install the software to their system when it became available. Customers were requested to take temporary measures until corrective measures were taken. 1) In dual scanoscopy, do not press the short key between the completion of the first scanoscopy and the start of the second scanoscopy. 2) In dual scanoscopy, do not click the (Scano Skip) button immediately before the completion of the first scanoscopy. 3) When the SplitCase function is set to ON, do not select two or more orders simultaneously from the appointment list. 4) When an image comment is to be preset by making a selection from the preset memo, do not select any image comment with more than 10 characters. Customers were asked to share the information with all users and reviewing radiologists as well as clinical engineering or Biomedical group at the facility. Customers were asked to complete and return the attached form and fax it to 877-349-3054. For any questions call (800) 421-1968 or contact your local Toshiba Representative at (800) 521-1968.

Device

  • Modelo / Serial
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution
  • Descripción del producto
    TSX-301B: AQUILION Premium; System, X-Ray, Tomography, Computed || X-Ray Tomography
  • Manufacturer

Manufacturer

  • Dirección del fabricante
    Toshiba American Medical Systems Inc, 2441 Michelle Dr, P.O. Box 2068, Tustin CA 92781-2068
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA