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 Leica Microsystems 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 097 08 18 000
  • Fecha de inicio del evento
    2018-08-29
  • 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=13095
  • 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
    Leica microsystems received five customer complaints stating that users inadvertently tipped over their leica m525 f20 microscope system. in four cases it was confirmed, that the issue occurred when users handled the microscope while the swing arm was in fully extended position (see figure 3 in the attached fsn). in all cases the leica m525 f20 did not cause or contribute to serious injury. the five complaints occurred in five different countries over a timeframe between the years 2010 and 2017. the leica m525 f20 was introduced in the year 2009 with more than 1000 instruments distributed globally up to date.

Device

Leica M525 F20
  • Modelo / Serial
    All Leica M525 F20 Microscope Systems
  • Descripción del producto
    Microscopes, Light, Operating
  • Manufacturer
    Leica Microsystems Inc.

Manufacturer

Leica Microsystems Inc.
  • Empresa matriz del fabricante (2017)
    Danaher Corporation
  • Representante del fabricante
    Al-Faisaliah Medical System
  • Source
    SFDA