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 IMPAC Medical Systems 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 115 07 13 000
  • Fecha de inicio del evento
    2013-07-17
  • 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=3981
  • 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
    Sample couch parameter files are supplied with monaco releases 3.10.00 and later. the user can access these files from the treatment couch library. by clicking on a particular couch file, the individual components of the couch can be selected and their densities edited. the user can then use the “save as treatment couch” to enter a unique name for the modified couch parameter file. the sample files and their default values are not intended for clinical use, and monaco was designed with the assumption that the user would rename the file when it was populated with actual, clinical values. when sample couch parameter files are edited, the densities altered, and “save” is selected, the sample files will be updated with these new, user defined densities. subsequently, when a software upgrade is loaded, under the conditions described below, the modified couch densities in these sample files will be overwritten with the default value of 1.000. this problem will affect upgrades to monaco releases 3.20.00 and 3.30.00 from release 3.10.00 or 3.20.00. the problem will occur during an upgrade if and only if – prior to the upgrade – a sample couch parameter file was edited and saved under the original name. the problem occurs because the upgrade installation script is designed to overwrite the sample couch files in the treatment couch library with the original default values.

Device

Radiation therapy treatment planning system, Monaco
  • Modelo / Serial
    Versions 3.10.00 and later (2011-12-19 - Present)
  • Descripción del producto
    Radiation therapy treatment planning system
  • Manufacturer
    IMPAC Medical Systems Inc

Manufacturer

IMPAC Medical Systems Inc
  • Empresa matriz del fabricante (2017)
    Elekta AB
  • Representante del fabricante
    Analysis Device For Medical and Scientific Service ( ADMSS ), Dammam, (013) 8174422
  • Source
    SFDA