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.

¿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 030 09 18 000
  • Fecha de inicio del evento
    2018-09-13
  • 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=13138
  • 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/ respironics everflo oxygen concentrator 1102443 has the electrical rating of 230v 60hz. however, one of the components inside the device, a compressor has a label indicating 230v 50hz, please see below figure 1. the same component also has additional label on the back side, see figure 2, this second label has the correct electrical frequencies 50/60 hz. therefore, our intent is to clarify presence of the two labels and assure of safe device performance. we would like to inform our customers that the philips everflo oxygen concentrator is fully compliant to iec 60601 and sfda.Md/iec 60601-1-1, as per sfda’s national provision article six. the shipping box (package) label and device label are provided in attachment.

Device

EverFlo (Oxygen Concentrator)
  • Modelo / Serial
    model 1102443
  • Descripción del producto
    Oxygen Concentrator
  • Manufacturer
    Philips

Manufacturer

Philips
  • Empresa matriz del fabricante (2017)
    Philips
  • Representante del fabricante
    Philips Healthcare Saudi Arabia Ltd.
  • Source
    SFDA