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 109 09 13 000
  • Fecha de inicio del evento
    2013-09-25
  • 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=4420
  • 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
    Cardiacvx and cardiacvx flow report higher than actual flow values on phase-contrast images acquired with magnitude weighting mask enabled. note that this issue can only occur on phase-contrast mr protocols with the magnitude weighting mask option enabled. in the fast cine phase-contrast sequence, the magnitude weighting mask is a user configurable option (control variable or cv). in the 2d cine phase-contrast sequence (non-fast mode), magnitude weighting mask is always on, and thus would always result in this issue. the issue may result in an incorrect diagnosis if higher than actual flow values are not noticed.

Device

Imaging system software, CardiacVX and CardiacVX Flow
  • Modelo / Serial
    CardiacVX (1.1.0 Ext. d) and CardiacVX Flow (1.1.0 Ext. d) analysis software running on Advantage Workstation
  • Descripción del producto
    Analysis software running on Advantage Workstation.
  • Manufacturer
    GE Healthcare

Manufacturer

GE Healthcare