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 Visionsense Ltd.

¿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 060 06 11 000
  • Fecha de inicio del evento
    2011-06-18
  • 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=535
  • 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
    May have an improperly sealed metal and glass window in the tip of the scope and possibly a mis-assembled camera head positioned behind the window. this combination of factors may lead to the metal and glass window becoming dislodged from the scope tip during cleaning and render the unit inoperable. the metal and glass window may also become dislodged during use therefore may represent a potential health hazard.

Device

Laparoscope Integrated Camera, VS II
  • Modelo / Serial
    VSII Laparoscope Integrated 0 Deg Camera. 30 Degree cameras are fit for use and are not affected by this recall.
  • Descripción del producto
    Cameras, Video, Endoscopic
  • Manufacturer
    Visionsense Ltd

Manufacturer

Visionsense Ltd