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 AGFA Corp..

¿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 100 11 18 000
  • Fecha de inicio del evento
    2018-11-28
  • 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=13549
  • 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 unit is equipped with safety measures so no movement may occur without user interaction. after an upgrade of the software of the overhead tube crane, there were isolated cases in which the overhead tube crane movement does not stop when the movement button is released. instead of stopping while the movement button is released, the tube head crane moves to the intended position. this issue only occurs with a specific combination of dedicated software versions with specific hardware board revisions.

Device

DX-D 600 X-ray system
  • Modelo / Serial
    This Safety Notice refers to your DR unit “DX-D 600” (DX-D 600 Automatic System, DX-D 600 Automatic Wall stand Only).
  • Descripción del producto
    Radiography x-ray imaging system
  • Manufacturer
    AGFA Corp.

Manufacturer

AGFA Corp.
  • Empresa matriz del fabricante (2017)
    Agfa-Gevaert NV
  • Representante del fabricante
    Gulf Medical Co.
  • Source
    SFDA