Events

Alerta De Seguridad para ARCHIVING AND IMAGE COMMUNICATION SYSTEMS (PACS) SYNGO IMAGING AND SYNGO PLAZA. Anvisa Registrations n ° 10234230146 (Syngo Imaging) in ° 10234230177 (Syngo Plaza).

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..

¿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
    1194
  • Fecha
    2012-10-22
  • 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
    Additional information in the Alert Messages released by Siemens, available at: http://portal.anvisa.gov.br/wps/wcm/connect/92c13f004d2ced31ae03fe4031a95fac/Messagem_de_Alerta_Syngo_Plaza.pdf?MOD=AJPERES and http://portal.anvisa.gov .br / wps / wcm / connect / 1d3081004d2cece7addcff4031a95fac / Message_of_Alerta_Syngo_Imaging.pdf? MOD = AJPERES
  • Causa
    Incorrect pixel density value for images with a pixel depth greater than 12 bits. the problem affects the "region of interest", "pixel lens", "edge enhancement" and "histograms" functions.
  • Acción
    The company is developing a new software version (Syngo Imaging XS VA70B_0113) to solve the problem, which should be available until March 2013. Until the problem is corrected you should not use the functions mentioned above for images with a depth of pixels larger than 12 bits. Let the operators know about the problem and fix a warning near the location of data acquisition / manipulation (images), informing about the restrictions of use of the system.

Device

ARCHIVING AND IMAGE COMMUNICATION SYSTEMS (PACS) SYNGO IMAGING AND SYNGO PLAZA. Anvisa Registrati...

Manufacturer

Siemens Ltda.
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    ANVSANVISA