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 Philips 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 015 10 12 000
  • Fecha de inicio del evento
    2012-10-08
  • 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=2460
  • 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
    1. when translating the calcium scoring (cs) results into chinese, the percentile is not reported accurately. 2. in the calcium scoring (cs) protocol, the protocol is switched to mass score but the protocol name remains agatston. 3. spline measurement values do not update when adding control point (cp) and when changing the length of the line. 4. in the ct viewer (ctv) pet studies being loaded from remote with slope different than 1, appear incorrectly in 2d scene and are not displayed with the correct suv values. 5. loading pet images in the ct viewer (ctv) \ quick review from remote with slope different than 1, the images with the different slope appear incorrectly with wrong suv values in perception and in qr.

Device

Computed tomography system, Extended Brilliance Workstation (EBW)
  • Modelo / Serial
    Extended Brilliance Workstation with running software version(s) 4.0.2, V4.5.2 or V4.5.3
  • Descripción del producto
    Computed tomography system
  • Manufacturer
    Philips Healthcare

Manufacturer

Philips Healthcare
  • Empresa matriz del fabricante (2017)
    Philips
  • Representante del fabricante
    Al-Faisaliah Medical System, Riyadh, (01) 2119948
  • Source
    SFDA