Events

Alerta De Seguridad para Trade Name: E.CAM SIGNATURE SERIES; registration 10234230040; hazard class III ///// Trade Name: SYMBIA SPECT / CT EQUIPMENT; model: Symbia T; Symbia T2; Symbia T6; Symbia T16; registration 10345161973; risk class III //// Trade Name: SPECT SYSTEM; model: Symbia E; Symbia S; registration 10345161991; class of risk II

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
    1947
  • Fecha
    2016-05-20
  • 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
    Recommendation to users and patients: Based on the results of our risk analysis, which indicates that the possibility of error is remote, we can continue to use the system. Make sure this notice is included in the instructions for use of the system. To reduce the chances of occurrence, follow the Shutdown and Startup instructions as described in the User's Guide. We also ask clients to wait for the update schedule to correct the error mentioned in the MI002-16-S Field Action Alert Message.
  • Causa
    Siemens healthcare has determined that e.Cam or symbia systems with predictive detectors performing dynamic or gateway acquisitions may lose detector / date information.
  • Acción
    Action code MI001 / 16 / S: Recommendations to users and patients ///// Software Update.

Device

Trade Name: E.CAM SIGNATURE SERIES; registration 10234230040; hazard class III ///// Trade Name: ...

Manufacturer

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