Events

Alerta De Seguridad para ACUSON Diagnostic Ultrasound System. Model: ACUSON S2000. Anvisa Registry n ° 10234230192.

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..

¿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
    1673
  • Fecha
    2015-09-01
  • 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
    The problem occurs when using the CIVCO biopsy connectors in combination with the ACUSON S Family screen orientations. The biopsy needle path may not correspond to the screen orientations and this occurs on the 6C1 HD and 18L6 HD transducers. The potential risk is not to obtain the tissue sample of interest. To avoid this problem, do not use the 6C1 HD and 18L6 HD transducers with the CIVCO biopsy connectors for guided biopsy procedures. For guided procedures with other transducers, follow the instructions given by Siemens in your customer letter, available at: http://portal.anvisa.gov.br/wps/wcm/connect/50122e8049b158f3a2adaada875a0177/Carta+Portugu%C3%AAs+ US016-15-S.pdf? MOD = AJPERES
  • Causa
    A problem may occur when using the civco biopsy connectors in combination with the acuson s family on-screen guidance. the path of the biopsy needle may not match the orientation of the screen. this may occur on 6c1 hd and 18l6 hd transducers.
  • Acción
    Information letter to customers, informing about the restriction of the use of 6C1 HD and 18L6 HD transducers with CIVCO biopsy connectors.

Device

ACUSON Diagnostic Ultrasound System. Model: ACUSON S2000. Anvisa Registry n ° 10234230192.

Manufacturer

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