Events

Alerta De Seguridad para ULTRASOUND DIAGNOSTIC SYSTEM ACUSON SC2000, Registration 10234230166 - Serial Numbers: 400294; 400723; 400758; 400762; 400831; 401532; 401704; 401809.

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 Medical Solutions USA, Inc.; Siemens Ltda.

¿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
    1690
  • Fecha
    2015-09-19
  • 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 informs that the potential risk is that the study data, including the measurements, are not captured and the study has to be performed again, extending the examination time to reacquire lost data and, in this case, the patient can be given extra dose of lidocaine or dobutamine.
  • Causa
    Siemens healthcare informs that the acuson sc2000 ultrasound system considers case / patient differences in the same patient name as unique occurrences of patients when registered on the same ultrasound system. the system recovers the sensitivity of uppercase and lowercase letters even though the original study has been removed from the hard disk. if these differences are not corrected at registration, the system will not capture images or clips.
  • Acción
    Siemens Healthcare recommends correcting case / patient case differences in patient name at the time of patient registration in order to avoid this problem. More information - Letter to the Client

Device

ULTRASOUND DIAGNOSTIC SYSTEM ACUSON SC2000, Registration 10234230166 - Serial Numbers: 400294; 40...

Manufacturer

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