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 087 07 13 000
  • Fecha de inicio del evento
    2013-07-14
  • 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=3948
  • 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 exhibit various out-of-context problems. safety issue : ( description, affected products details); safety issue #1 : ( in centricity ris-ic, and a ris-driven integration, the “close” button closes the exam in ris-ic, but does not close the exam in centricity pacs ra1000 workstation, centricity pacs versions 3.2.2.3 and forward are affected ); safety issue #2 : ( interrupted workflow could break the synchronization between nuance powerscribe 360 and centricity pacs ra1000 workstation, centricity pacs versions 3.2 and forward are affected ); safety issue #3 : ( interrupted workflow could break the synchronization between agfa talk and centricity pacs ra1000 workstation, centricity pacs versions 3.1.1.2 and forward are affected ); safety issue #4 : ( centricity pacs ra1000 workstation distance measurements may not be calculated accurately when a modality sends a study to pacs which only contains values in the imager pixel spacing (0018, 1164), and magnification factor (0018, 1114) dicom tags but does not include a value in the pixel spacing (0020,0030) dicom tag, centricity pacs versions 2.X and forward).

Device

Centricity PACS RA1000 Workstations
  • Modelo / Serial
    Centricity PACS versions ( 2.1.5.6; 2.1.5.8; 2.1.5.9; 2.1.5.10; 2.1.5.11; 2.1.5.13; 3.1.1.2; 3.2; 3.2.0.1; 3.2.0.2; 3.2.1; 3.2.2; 3.2.2.1; 3.2.2.2; 3.2.2.3; 3.2.6; 3.2 SP7; 4.0; 4.0.1 )
  • Descripción del producto
    Workstations, Picture Archiving and Communication System
  • Manufacturer
    GE Healthcare

Manufacturer

GE Healthcare