Events

translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice

Según Saudi Food & Drug Authority, este evento ( translation missing: es.activerecord.attributes.event.types.recall_field_safety_notice ) involucró a un dispositivo médico en Saudi Arabia que fue producido por SIEMENS.

¿Qué es esto?

Las notificaciones de seguridad de campo son comunicaciones sobre acciones que se pueden estar tomando en relación con un producto que se encuentra en el mercado, enviadas por los fabricantes de dispositivos médicos o sus representantes. Estas notificaciones son principalmente para trabajadores de la salud, pero también para usuarios. Pueden incluir alertas y retiro de equipos.

Más información acerca de la data acá
  • Tipo de evento
    Recall / Field Safety Notice
  • ID del evento
    mdprc 088 07 12 000
  • Fecha de inicio del evento
    2012-07-23
  • País del evento
    Saudi Arabia
  • Fuente del evento
    SFDA
  • URL de la fuente del evento
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=2123
  • Notas / Alertas
    Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 recall data from the U.S. and Saudi Arabia.
  • Notas adicionales en la data
    Report Source: NCMDR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Causa
    The issue is isolated images of pixel depth greater than 12 bit (99% of all stored images). problem exists prior to va20d as well" analysis showed that this behaviour is caused by a software bug. in some situations it can happen that a miscalculation is done for the grey scale values in the functions "region of interest", "pixel lens", "edge enhancement" and "histograms". the min/max value of pixel density in the functions "region of interest", "pixel lens", "edge enhancement" and "histograms" is not correct for images with a pixel depth greater than 12 bit. it has to be noted that the mentioned measurements shown in prior images are also not correct. all values which are calculated for images with a pixel depth less than or equal to 12 bits are correct.

Device

Picture archiving and communication system, radiology, Syngo. Plaza and Syngo Imaging XS
  • Modelo / Serial
    (1) System Label 10592 457 System version:VA20D (2) System Label104 96 279 System version:All versions VA70 and higher are affected
  • Descripción del producto
    picture archiving and communication system
  • Manufacturer
    SIEMENS

Manufacturer

SIEMENS
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Representante del fabricante
    Siemens Medical Solutions, Jeddah, (02) 6602933
  • Source
    SFDA