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 Medical Systems..

¿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 033 01 11 000
  • Fecha de inicio del evento
    2011-01-17
  • 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=5&rid=48
  • 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: http://www.sfda.gov.sa/En/MedicalEquipments/recalls/NCAR+Brief.htm
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Causa
    1. when using the center on cursor feature in combination with a blended drr in certain advantagesim versions, the captured drr will remain fixed in the original position while the active drr will move to a position where the 3d cursor is centered on the screen. 2. when using the isocenter move mode feature in combination with a blended drr in certain advantagesim versions, the captured drr will remain fixed in the original position while the active drr is correctly recalculated and shown. 3. when the image series is changed (on the top left corner of a drr view) while using drr blending, the captured drr is not recalculated or cancelled. 4. when using the blended drr function the visualization of the captured drr may change without the visualization parameters (mixing and depth control) being updated on-screen after choosing a drr preset for the active drr. 5. when a new beam is created after using drr blending on a previous beam, switching back to the previous beam may cause annotations for blending, mixing and depth control to not be shown.

Device

Advantage Sim MD.
  • Modelo / Serial
    Software version: 5.x, 6.x, 7.x
  • Descripción del producto
    Software for X-ray system, used for radiotherapy.
  • Manufacturer
    GE Medical Systems.

Manufacturer

GE Medical Systems.
  • Empresa matriz del fabricante (2017)
    General Electric Company
  • Representante del fabricante
    GE Healthcare., Riyadh, (01) 4600530
  • Source
    SFDA