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 146 03 14 000
  • Fecha de inicio del evento
    2014-03-31
  • 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=5567
  • 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
    The shaft of the type 01 elbow motor for exact arms used in the on-board imager® [obi] device have failed due to belt over-tensioning. this over tensioning would have taken place during servicing. this failure would allow the exact arm to swing freely with gravity. no injuries have been reported to-date. only type 01 elbow motors are subject to these potential failures, type 02 elbow motors are not affected.

Device

On-Board Imager
  • Modelo / Serial
    Type 01 Elbow Motors
  • Descripción del producto
    On-board imaging (OBI) refers to the use of daily x-rays (taken right on the linear accelerator) that help to confirm a match of treatment setup to the planned treatment.
  • 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