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 039 07 18 000
  • Fecha de inicio del evento
    2018-07-05
  • 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=12874
  • 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
    It was reported that scanners running software versions 4.1.6 (brilliance ict and ingenuity ct), 4.2 (brilliance bigbore), and 4.7.0 and 4.7.2 (iqon) with the heartbeat cs pro option provide confusing information in the “impressions” section of the calcium score report. the generated report provides multiple analyses of the amount of plaque detected, as if they all apply to the patient at the same time.

Device

Brilliance 64, Brilliance CT BigBore, Brilliance iCT,
  • Modelo / Serial
    Brilliance 64, Brilliance iCT, Brilliance iCT SP, Ingenuity Core, Ingenuity Core128, and Ingenuity CT with software version 4.1.6 Brilliance CT BigBore and with software version 4.2.0 IQon Spectral CT with software versions 4.7.0 and 4.7.2
  • Descripción del producto
    Scanning Systems, Computed Tomography
  • Manufacturer
    Philips Healthcare

Manufacturer

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