Events

Alerta De Seguridad para Trade name of the product: SYMBIA MARCA SIEMENS SPECT / CT EQUIPMENT (registration number: 10345161973); SPECT SYSTEM (registration number: 10345161991), E.CAM SIGNATURE SERIES MARK SIEMENS (registration number: 10234230040) /// affected lots: see file "Product description MI002 / 16 / S.pdf" / / Product risk class : II and III.

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
    1879
  • Fecha
    2016-04-21
  • 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
  • Causa
    The company "has determined that e.Cam or symbia systems with predictive detectors performing dynamic or gateway acquisitions may lose detector date / time information." research shows that "the resulting risk is that the image data frame and the ejection fraction value calculated are smaller. although erroneous diagnoses are a possibility, if ejection fraction values ​​are used as the sole source of diagnosis, we were not informed of such events. ".
  • Acción
    Field classification: letter to client /// Field action code: MI002 / 16 / S /// Recommendations to users and patients: one can continue to use the system; make sure that this warning is included in the instructions for use of the system. We also ask that customers await the release of the update that aims to correct the error mentioned in this field action. To reduce the chances of occurrence, follow the Shutdown and Startup instructions as described in the User's Guide.

Device

Trade name of the product: SYMBIA MARCA SIEMENS SPECT / CT EQUIPMENT (registration number: 103451...

Manufacturer

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