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 Philips Healthcare.

¿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 001 04 12 000
  • Fecha de inicio del evento
    2012-04-03
  • 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=1632
  • 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
    Philips healthcare has received reports of three occurrences where the monitor ceiling suspension system fell to its lowest position. in one occasion it collided with the table top. no patient harm has been reported. the investigation initiated concluded that the cause of the failure was an assembly error of the actuator of the mcs.

Device

Radiographic/Fluoroscopic Systems
  • Modelo / Serial
    System: Allura Systems FD10 , FD20, FD10/10, FD20/10 and FD20/20 (*) shipped between November 15th 2011 and March 15th 2012 that include an Actuator with an assembly error (Actuator Short Assy: 989600-184-665 and Actuator Long Assy: 989600-184-654). A limited number of Allura Sytems (3 FD10 and 1 FD20/20) (**) in which the Actuator has been replaced by an Actuator with an assembly error. (*) Productcodes: 722010, 722011, 722012, 722013, 722014, 722015, 722019, 722020, 722022, 722023, 722024, 722025 (**) Product codes: 722001, 722003 and 722008
  • Descripción del producto
    Radiographic/Fluoroscopic Systems, Angiography/Interventional
  • Manufacturer
    Philips Healthcare

Manufacturer

Philips Healthcare
  • Empresa matriz del fabricante (2017)
    Philips
  • Representante del fabricante
    Al-Faisaliah Medical System, Riyadh, (01) 2119948
  • Source
    SFDA