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 Elekta Limited.

¿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 182 07 13 001
  • Fecha de inicio del evento
    2013-11-05
  • País del evento
  • Fuente del evento
    SFDA
  • 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
    With the current design, it is necessary for the stereotactic practitioner to implement processes and protocols, to manage the clinical application of these devices, and to be fully trained and current on the complete process of stereotactic radiosurgery. the likely contributing factors to errors in the clinical workflow which fall under this management are: • the installation of an incorrect cone. • the use of a consolidated field with an incorrect cone. • for a manually input prescription, an incorrect diaphragm setting in mosaiq. • an incorrect diaphragm setting in the treatment planning system . • an incorrect diaphragm setting in standard therapy a failure to manage these conditions can cause clinical mistreatment.

Device

  • Modelo / Serial
    MRT 13521 ............................ FDA Update codes : ( 933, 935, 936, 937, 940, 843, 844, 845, 846, 847, 833, 834, 835, 836, 837, 801, 802, 803, 804, 805, 908, 909, 910, 911, 912, 889, 890, 891, 892, 893, 894, 848, 849, 850, 851, 852, 853, 974, 975, 976, 977, 978, 1032, 1033, 1034, 928, 929, 930, 931, 932, 980, 981, 982, 983, 984, 1017, 1018, 1019, 1020, 1021, 883, 884, 885, 886, 1012, 1013, 1014, 1015, 1016, 1027, 1028, 1029, 1030, 1031, 941, 942, 943, 944, 945, 946, 947, 948, 949, 950, 903, 904, 905, 906, 907 )
  • Descripción del producto
    The Stereotactic Collimator is an add-on device used for the collimation of photon beams on a digital accelerator. The collimator focuses the photon beam inside a conical aperture of known dimensions. This additional collimation creates a very fine circular radiation beam.
  • Manufacturer

Manufacturer

  • Empresa matriz del fabricante (2017)
  • Representante del fabricante
    Analysis Device For Medical and Scientific Service ( ADMSS )
  • Source
    SFDA