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 210 08 15 000
  • Fecha de inicio del evento
    2015-08-30
  • 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=8162
  • 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
    Incorrect treatment delivery using third party fixed wedges. when fixed wedges are defined in source file maintenance, the user defines a maximum field size allowed for each wedge. this maximum field size is being ignored by the software when both fixed wedges and mlcs are present in a beam. the result is incorrect calculation and delivery of dose outside the physical extent of the wedge. the dose distribution calculated by xio will not match the dose delivered to the patient in regions beyond the physical dimension of the wedge. varian and siemens linacs will prevent delivery. elekta linacs with motorized wedges will prevent delivery. elekta linacs with third party fixed wedges will not prevent delivery.

Device

XiO Radiation Treatment Planning Systems
  • Modelo / Serial
    Sites affected will be those: 1. Running XiO Release 4.51 and higher, and 2. Using Elekta linacs, and 3. Using third party fixed wedges in combination with MLCs
  • Descripción del producto
    Radiation Treatment Planning System
  • 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