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 057 04 12 000
  • Fecha de inicio del evento
    2012-04-17
  • 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=1688
  • 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
    When using the fmri protocol in ready view, the ready view application may incorrectly sort the phases of the fmri native data set. this happens when the fmri data was acquired using the brainwave rt acquisition scheme on the mr console. no adverse event has been reported related to this issue. this affects the analysis of the image set made by the correlation algorithm used in the fmri protocol. as a result, activated pixels identified as having a high correlation with a reference pattern may not be correctly identified.

Device

Workstation software, READY View
  • Modelo / Serial
    READY View version 10.3.67 is affected; PR# 7130256 to AFSSAPS (reference 201205472)
  • Descripción del producto
    Workstation software, analyzing fMRI images
  • Manufacturer
    GE Healthcare

Manufacturer

GE Healthcare