Alerta De Seguridad para X-ray Generator, X-ray Generator Set (1) Model KXO-50R, (2) Model KXO-50F, Model KXO-80N

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
    676
  • Fecha
    2001-10-26
  • País del evento
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
  • 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
    BRASIL-03.10.2002 / Letter from the company Toshiba Medical do Brasil Ltda, C-0340RX.2002, dated 27.03.2002, informs that the corrections are already being carried out with customers with the X-ray generator, model KXO 50- F. In addition, it covers not only the referenced model, but also the KXO-30R, KXO-30F, KXO-50N and KXO-80N models. -------------------------------------------------- ---------------------- On July 29, 2002, C-084RX.2002, the company Toshiba Medical do Brasil Ltda, announces the closure of the adequacy procedures of generators. Circuit Modification as instructed by Toshiba Corporation, Medical Sistems Division (Field Modification Instruction FMI - XR863) to conform to international standard CFR1020.31.
  • Causa
    The above x-ray controls / generators did not meet the 21 cfr 1020.31 (a) (2) requirements since uninterrupted exposure may occur as a result of tube bending. the manufacturer initiated a correction by letter dated july 19, 2001.
  • Acción
    Verify receipt of letter and safety instructions from Toshiba America Medical Systems x-ray generator dated July 19, 2001. Identify all affected products in your inventory. Follow the instructions for safety use of the x-ray generators. For more information, contact your legal representative.

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