Events

Alerta De Seguridad para DIAGNOSTIC ULTRASOUND SYSTEM, model ACUSON SC2000 -. registry 10345161999 - Class of risk II. Serial Numbers: 400758; 400762; 400831; 400723 and 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 Healthcare Diagnósticos S.A.; 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
    1811
  • Fecha
    2016-02-03
  • 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
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Causa
    When registering the patient's name on the acuson sc2000 ultrasound system, case / patient differences are considered when describing the patient name. if the differences are not corrected at registration, the system will not capture the images or clips with a potential risk that the study data, including the measurements, will not be captured and the study must be performed again, extending the examination time to reacquire missing data.
  • Acción
    Software update. Action code US030 / 15 / S and US031 / 15 / S. //////////// Recommendation to users and patients: the user should file all patient data before the software update starts. ///////// In addition, while updating software is not performed, the recommendation of Portuguese Letter US024 / 15 / S is maintained, which says: in order to avoid the problem of registering the patient's name, the user must correct the differences in uppercase / lowercase letters in the patient's name at the time of registration.

Device

DIAGNOSTIC ULTRASOUND SYSTEM, model ACUSON SC2000 -. registry 10345161999 - Class of risk II. Ser...

Manufacturer

Siemens Healthcare Diagnósticos S.A.; Siemens Medical Solutions USA, Inc.
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    ANVSANVISA