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 121 07 18 000
  • Fecha de inicio del evento
    2018-07-24
  • 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=12959
  • 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 received a complaint reporting that a monitor ceiling suspension (mcs) with a flexvision 56-inch large screen fell to the ground. the actuator assembly of the mcs became detached and the monitor carriage with the flexvision monitor dropped to the ground. the monitor ceiling suspension is designed to allow flexible positioning near the patient table when in use, and away from the patient table when not in use. (parked position).

Device

Allura Xper, integris systems.
  • Modelo / Serial
    All systems mentioned in the attached file that were delivered with an actuator for the FlexVision Monitor Ceiling Suspension in the period 2003 to May 201 1 are affected. Allura Xper FD10 C : 722001 Allura Xper FD10 F : 722002 - Please check attachment for all AFFECTED PRODUCTS -
  • Descripción del producto
    Monitor Ceiling Suspension (MCS)
  • Manufacturer
    Philips Healthcare

Manufacturer

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