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 075 08 14 001
  • Fecha de inicio del evento
    2014-08-19
  • 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=6318
  • 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: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=129099
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Causa
    Problem 1: when reopening a bookmark generated from processing a muga (multi-gated acquisition) scan within the nm cardiac application, the ejection fraction (ef) displayed should be the same as the ejection fraction (ef) originally displayed when the bookmark was first created. in some instances, the ejection fraction (ef) may be different. problem 2: when processing using one of the following nm clinical applications: autoquant, emory cardiac toolbox, corridor4dm, or neuroq, the patient study presented to the reviewing physician within the application may be for a different patient than the one selected from the patient directory. note: the data presented to the reviewing physician is the data for the patient presented by the application labeling. problem 3: while using the nm viewer application, an arrow annotation added to a display moves away from its original position if the viewer is subsequently maximized or if the image within the viewer is subsequently zoomed in or out. problem 4: while displaying pet images within ct viewer, the suv results displayed may be calculated with an suv method different from the one specified in system preferences. this issue affects the ct viewer and multi- modality tumor tracking applications. the expected behavior in such a case is that the application displays a warning that suv cannot be calculated due to missing information, and the images are displayed with the original acquisition units (bq/ml). instead, in affected systems, if the patient height has not been entered and the selected suv calculation method requires height data (i.E., suv-bsa), the system may display an suv calculated using a different method (suv-bw) without providing any warning that required data had not been entered or informing the user of the change.

Device

IntelliSpace Portal Software Versions 5 and 6
  • Modelo / Serial
    - IntelliSpace Portal DX/HX/EX, Software Versions 5 and 6 - IntelliSpace Portal IX, Software Versions 5 and 6 - IntelliSpace Portal LX SPECT, Software Versions 5 and 6 ………………………………….. Update code from FDA : - Please check attached file for lot numbers –
  • Descripción del producto
    Workstations for Medical Imaging 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