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 GE Healthcare.

¿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 049 12 11 000
  • Fecha de inicio del evento
    2011-12-11
  • 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=1152
  • 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
    May display incorrect patient name on images (volume viewer) or tabs (results viewer). issue 1: on monitors with 2 megapixel (2mp) resolution, switching between two volume viewer tabs with different patients, the topmost strip of the volume viewer display fails to update between patients. issue 2: when starting the results viewer application in the aws client window for a particular patient exam, if a second patient exam is selected while the application is starting, the results viewer will display the second patient’s image data and name in the viewports; however, the first patient name will display on the applications tab.

Device

Workstations, Radiotherapy, Planning. Advantage Workstation Servers
  • Modelo / Serial
    Advantage Workstation Servers (AWS): Software Version 2.0; Release Version 2.0-4.0
  • Descripción del producto
    Workstations, Radiotherapy, Planning
  • Manufacturer
    GE Healthcare

Manufacturer

GE Healthcare