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 Gamma Cameras.

¿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 086 08 17 000
  • Fecha de inicio del evento
    2017-08-24
  • 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=11452
  • 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
    In order to save archiving space, the allura xper r9 systems and azurion r1.1 systems include the option of downscaling the image when exporting images to the external dicom destination (e.G., pacs). when using the downscale option, the measurements performed with the allura r9 system or azurion r1.1 system using the qa basic measurement tool will not be correctly exported to the external dicom destination. the difference between the original measurement and the exported measurement can vary. the distance value after export is factor 1 to 4 smaller than the original value. the difference will depend on the acquired image (e.G., x-ray protocol, field of view) and the used archive settings (i.E., downscale settings).

Device

Allura Xper R9 and Azurion R1.1
  • Modelo / Serial
    Allura Xper R9 and Azurion R1.1 systems with the QA Basic Measurement tool. Product names: Allura Xper R9 7M12, Allura Xper R9 7M20, Azurion 7M12; Azurion 7M20; Azurion 3M12; Azurion 3M15
  • Descripción del producto
    imaging systems
  • Manufacturer
    Philips Healthcare Gamma Cameras

Manufacturer

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