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 Terumo Cardiovascular 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 147 10 18 000
  • Fecha de inicio del evento
    2018-10-30
  • 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=13402
  • 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
    This purpose of this medical device correction is to provide users with a revised version of the virtuosaph plus endoscopic vessel harvesting system (vsp550ex) instructions for use (ifu). the vsp550ex ifu contains a list of generators that terumo cardiovascular systems (cvs) has deemed compatible with the vsp550ex device. in response to recent reports received by terumo cvs, it has been determined that the valleylab ft10 energy platform is not compatible with the virtuosaph plus evh system. therefore, the valleylab ft10 has been removed from the list of compatible generators within the vsp550ex ifu.

Device

VirtuoSaph Plus Endoscopic Vessel Harvesting SystemVirtuoSaph Plus Endoscopic Vessel Harvesting S...
  • Modelo / Serial
    Catalog Number: VSP550EX Lot Numbers: 81K
  • Descripción del producto
    Electrosurgical, cutting & coagulation & accessories
  • Manufacturer
    Terumo Cardiovascular Systems

Manufacturer

Terumo Cardiovascular Systems
  • Empresa matriz del fabricante (2017)
    Terumo Corp.
  • Representante del fabricante
    ABDULREHMAN AL GOSAIBI GTB
  • Source
    SFDA