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 Varian 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 049 11 11 000
  • Fecha de inicio del evento
    2011-11-11
  • 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=1023
  • 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: NCAR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Causa
    If the user selects the “convert to setup field” option when using the rt chart function in aria (versions 8.0 and 8.1), the dynamic multi leaf collimator (dmlc) plan components are removed in order to create an open collimator for field light setup. in the reported case (cp-03045 from the usa) a user selected this option in error and then converted the set-up field back to a treatment field. the dmlc was then missing from the resultant treatment field. if this error is not detected prior to patient treatment an open field treatment can result.

Device

COMPUTER TREATMENT PLANNING
  • Modelo / Serial
    ARIA RT Chart Application v8.0 and 8.1
  • Descripción del producto
    Radiotherapy Systems, Linear Accelerator
  • Manufacturer
    Varian Medical Systems

Manufacturer

Varian Medical Systems
  • Empresa matriz del fabricante (2017)
    Varian Medical Systems, Inc
  • Representante del fabricante
    Varian Medical Systems, Riyadh, (01) 2772126
  • Source
    SFDA