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 Elekta Inc.

¿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 085 04 12 000
  • Fecha de inicio del evento
    2012-04-24
  • 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=1716
  • 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 is possible that the backup diaphragms drive mechanism can become loose after many years in clinical operation. this can cause a backlash between the positioning mechanism and the diaphragm. this backlash can be seen by the usual x-ray and field calibration checks when the field is moved from a small to a large field size. if there is a problem it will be that the backup diaphragm is not in the correct position behind the mlc leaf tips. if you do not do the recommended planned maintenance program, screws can become lost from the positioning mechanism. if you find one or more screws, do not use the machine for clinical operation, and find the cause.

Device

Radiology, X-ray, MLCi and MLCi2 radiation heads
  • Modelo / Serial
    All MLCi and MLCi2 radiation heads.
  • Descripción del producto
    Radiology, X-ray
  • Manufacturer
    Elekta Inc

Manufacturer

Elekta Inc
  • Empresa matriz del fabricante (2017)
    Elekta AB
  • Representante del fabricante
    Analysis Device For Medical and Scientific Service ( ADMSS )
  • Source
    SFDA