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 049 10 17 000
  • Fecha de inicio del evento
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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
    Issue 1: cardiac signal not found in workflow issue if the operator loads a cardiac exam card, the cardiac signal is shown during cardiac scan but not shown during the surview. issue 2: scan may start at the top of the head, which may not be where the operator is expecting the scan to start if the operator plans to do multiple scans with multiple results including identical links then the first result of the subsequent acquisition will follow the last result of previous acquisition and not the identical link of the previous acquisition. the possible outcome is that the results of the second scan could be planned outside the boundaries of the expected results. issue 3: pulmo gates on cardiac workflow issue if the operator loads a cardiac exam card after performing a pulmonary scan, the pulmo wave may be present. ‘ issue 4: in the plan viewer if the start position is modified the total length of the acquisition will changes as well. in the plan viewer if the start position is modified by the length of one slice thickness, then the total length of the acquisition may change by the same length value as well. note this occurs only when planning without a surview. issue 5: image volumes are not found in patient directory when thin images are included in one of the multiple results the operator completes a ct orbit procedure and clicks end study’. the final thin images may not appear in patient directory. when the operator clicks ‘recon’ to attempt to do an off-line recon the ‘view 2 application may fail. issue 6: application may fail when modifying the results plan box during 3d calcium score while setting up a 3d calcium score scan, if the operator attempts to modify the plan box of a result on the surview, the application may fail and require a restart. issue 7; tube too hot the operator presses go’ to execute a timed scan sequence and the following message may display: “tube too hot”. issue 8: memory overflow issue when performing a ct clinical procedure, it is possible that the scan may be aborted as a result of a memory overflow issue. issue 9: while the reconstruction is in progress disconnecting the recon box (cirs) may not give error message when the connection between host computer and recon box (cirs) is disrupted during reconstruction, the operator may not be informed and may require that the operator reconstruct the images through off-line reconstruction. issue 10: issue with the generatormonitor state machine in rhost code issue when the operator turns the key switch on the ct box to off and turns it back on before the system gantry is turned off completely the system might make the generator to go into a configuration state and ceases to monitor and to send the updated real time data for the tube’s kv and ma.


  • Modelo / Serial
    Brilliance 64 728231 Ingenuity Core 728321 Ingenuity 1C2or8e 728323 Ingenuity CT 728326 : Running software version: 4.1,6 The products affected will display one of the following software versions: V4.1 .6.XXOSO V4.1 .6.XX032
  • Descripción del producto
    Computed Tomography
  • Manufacturer


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