Events

Retiro De Equipo (Recall) de Device Recall Aquillion One TSX301A/2D

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
    69748
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0472-2015
  • Fecha de inicio del evento
    2014-11-05
  • Fecha de publicación del evento
    2014-11-26
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-10-09
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131699
  • 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
    Potential problem with the cardiac function analysis software (cfa). incorrect analysis results may be displayed in the function parameters for the entire heart displayed as analysis results of the cfa and in a left-ventricular volume curve generated based on some of those parameters.
  • Acción
    Toshiba sent an Urgent Medical Device Correction letter dated November 5, 2014, to all affected customers. Customers were asked to refrain from using the function parameters for the entire heart and the left-ventricular volume curve until corrective actions have been taken. Customers were instructed to share this information with all users and reviewing radiologist as well as clinical engineering or Biomedical group at facility. Please complete and return the attached form and fax it to the toll free number at the top of the form 877-349-3054. This form can also be sent via email to raffairs@tams.com. Revised software to prevent occurrence of this problem will be installed on the system. When the new software becomes available the Toshiba service representative will contact for an appointment to install it on the system. Customers with questions were instructed to call 800-421-1968 or contact their local Toshiba Representative at 800-521-1968.

Device

Device Recall Aquillion One TSX301A/2D
  • Modelo / Serial
    Item CFA Software Serial Number: Description TSX-301A/2D 1BA07X2002 Aquilion One TSX-301A/2D 1BA07X2001 Aquilion One
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Nationwide Distribution to CA, MA, MD
  • Descripción del producto
    Cardiac Function Analysis Software || Product Data No. MPDCT0301EAD || CSCF-003A || The software is applicable to the following CT systems: || Aquilion ONE TSX-301A/2D || X-ray CT system with a 320-row 0.5 mm detector is provided with a 7.5-MHU large-capacity X-ray tube unit, and permits scanning over large areas at the high-speed of 0.35 s per rotation. The system features are; 160-mm-wide area detector, station, gantry and patient couch operation controls, image reconstruction, high-speed volume scan, high-quality images, selectable image slice thickness, dual-monitor system, improved image diagnosis functions, high-speed volume data workflow, exposure reduction, ECG-gated scan and reconstruction, and SUREFluoro.
  • Manufacturer
    Toshiba American Medical Systems Inc

Manufacturer

Toshiba American Medical Systems Inc
  • Dirección del fabricante
    Toshiba American Medical Systems Inc, 2441 Michelle Dr, P.O. Box 2068, Tustin CA 92780-7047
  • Empresa matriz del fabricante (2017)
    Canon Inc
  • Source
    USFDA