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 097 10 16 000
  • Fecha de inicio del evento
    2016-10-13
  • 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=10074
  • 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
    The thickness and location of the shielding material must be installed according to the shielding requirements provided by philips. in cases where the requirements are not followed, the distance between the passive shielding rear wall and the magnet could be insufficient. an insufficient distance leads to stronger attraction forces between the magnet and the passive shielding. these stronger forces may lead to shearing of the magnet vibration pads. in a worst case scenario, it may result in displacement of the magnet. displacement of a magnet can result in image quality issues and mechanical fitting problems with the table. these functional issues affect the clinical usage of the mr system.

Device

Achieva 3.0T and Ingenia 3.0T MR systems with passive shielding in the rear wall.
  • Modelo / Serial
    MR systems have a strong magnetic field around the magnet, the so called fringe field. Reduction of this fringe field (e.g. 0.5-mT area) can be required under certain circumstances. A reduction can be achieved with ferromagnetic plates mounted to the parent walls, under the construction floor and above the RF-ceiling. These plates are called passive shielding. Passive shielding calculations require dedicated Philips Healthcare software. As documented in the Planning Reference Documentation, these calculations must be performed by Philips. It provides the requirements for the thickness and the location of the shielding material which are to be implemented, preferably by Philips’ selected RF cage suppliers.
  • Descripción del producto
    MR systems
  • Manufacturer
    Philips Healthcare

Manufacturer

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