Events

Alerta De Seguridad para Trade Name: ACUSON SC2000 ULTRASOUND DIAGNOSTIC SYSTEM. ANVISA registration no. 10345161999. Risk class II. Serial numbers: 400294.

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
    1943
  • Fecha
    2016-07-08
  • 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
    If you have any questions regarding this field action, please contact Siemens Healthcare by telephone: 0800 129 633
  • Causa
    Siemens healthcare diagnósticos sa informs that the field action us014 / 16 / s consists of the software update. when using the device with outdated software, it is possible that when you acquire an image with a transesophageal transducer (tee) (z6ms, v5ms or v7m), you may lose the ability to control the colored region of interest, sample, or pulsed or continuous wave doppler, the m mode strokes, the 2d field of view or the res region of interest with the trackball. in addition, the acuson sc2000 device considers case / patient case differences in the same patient name as unique patient occurrences 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. when these differences are not corrected at registration, the system will not capture images or clips.
  • Acción
    Action code US014 / 16 / S. Sending of Letter to the Clients // Software Update.

Device

Trade Name: ACUSON SC2000 ULTRASOUND DIAGNOSTIC SYSTEM. ANVISA registration no. 10345161999. Risk...

Manufacturer

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