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 Accuray 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 015 10 18 000
  • Fecha de inicio del evento
    2018-10-07
  • 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=13263
  • 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
    Accuray incorporated (accuray) has been informed of two issues related to components of the robot contained within the cyberknife® m6™ system. the issues involve the wrist assembly which is the final linkage between the robot arm and the linear accelerator. one issue relates to the fastening process for the wrist assembly which may not have been implemented properly for specific units. the second involves incorrect material being used in a small number of wrist castings. these issues may lead to premature wrist failure, resulting in a linear accelerator fall.

Device

CyberKnife M6 System
  • Modelo / Serial
    Only Accuray CyberKnife M6 Systems may potentially be affected by these issues.
  • Descripción del producto
    Stereotactic Systems, Image-Guided, Radiosurgical, Linear Accelerator
  • Manufacturer
    Accuray Inc.

Manufacturer

Accuray Inc.
  • Empresa matriz del fabricante (2017)
    Accuray Inc
  • Representante del fabricante
    Gulf Medical Co.
  • Source
    SFDA