Events

Alerta De Seguridad para ULTRASOUND DIAGNOSTIC SYSTEM ACUSON SC2000, Registration 10234230166 - Serial Numbers: 400723; 400758; 401532.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Siemens Ltda.; Siemens AG; Siemens Medical Solutions USA, 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
    1679
  • Fecha
    2015-08-26
  • 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
    Siemens Ltda reports the potential risk is that the Echocardiogram under Effort study must be performed again. It further informs that the problem will be solved by launching new software for customers who have not yet received the original software update.
  • Causa
    Siemens healthcare has identified that when conducting a 2d stress echocardiography study, there is a possibility of data loss in the acuson sc2000 system, in which selected videos can not be saved as part of the study.
  • Acción
    The company advises that, in order to avoid possible risk, the following steps should be followed: - Select "Stress echocardiography"; - If applicable, reclassify videos from all stages and views; - Do not return to "Stress Echo Screening" to select reclassified additional videos. In addition, after inserting the stress echocardiography review, the selection of stress echocardiography should not be reinserted and additional images or videos should be selected. For more information, see Appendix Letter to the customer and through the company service center.

Device

ULTRASOUND DIAGNOSTIC SYSTEM ACUSON SC2000, Registration 10234230166 - Serial Numbers: 400723; 40...

Manufacturer

Siemens Ltda.; Siemens AG; Siemens Medical Solutions USA, Inc.
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    ANVSANVISA