Events

Alerta De Seguridad para Computed Tomography Fluoroscopic Option Software for Use with the TSX-101A Aquilion and Model TSX-021A Asteion Computed Tomography Scanners: (1) Model TSFX-003A, (2) Model TSFX-003B, (3) Model TSFX-003C

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Toshiba America Medical Systems Inc.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    177
  • Fecha
    2001-05-10
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 data from the U.S. and Brazil.
  • Notas adicionales en la data
    BRAZIL - 11/21/2001 - THE COMPANY REPORTS THAT THE CORRECTION OF THE PRODUCT WAS OCCURRED BY A BUG OF SOFTWARE RELEVANT TO THE OPTIONAL STUDIED CT FLUOROSCOPY SYSTEM MODEL TSXF-003A, TSXF-003B AND TSFX-003C, THAT MAY BE INCORPORATED IN AQUILION COMPUTERIZED TOMOGRAPHY SYSTEMS TSX-101A AND ASTEION TSX-021A, AND THAT FOR BRAZIL, EQUIPMENT WAS NOT IMPORTED WITH THIS OPTIONAL, BEING EXCLUDED OF CORRECTIVE NECESSARY.
  • Causa
    X-ray generation may occur without command of the operator when an unusual sequence program is used. the importer initiated a recall through correspondence sent on may 10, 2001.
  • Acción
    Make sure that you have received the correspondence sent on May 10, 2001 by Toshiba America Medical Systems (TAMS). Follow the instructions given to avoid the above mentioned problem. New software will be distributed August 31, 2001, to correct the problem. For more information, contact TAMS at (800) 421-1968

Device

Computed Tomography Fluoroscopic Option Software for Use with the TSX-101A Aquilion and Model TSX...

Manufacturer

Toshiba America Medical Systems Inc
  • Source
    ANVSANVISA