Events

translation missing: en.activerecord.attributes.event.titles.recall_field_safety_notice

According to Saudi Food & Drug Authority, this translation missing: en.activerecord.attributes.event.types.recall_field_safety_notice involved a device in Saudi Arabia that was produced by Elekta Limited.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Recall / Field Safety Notice
  • Event ID
    mdprc 182 07 13 001
  • Event Initiated Date
    2013-11-05
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=4676
  • Notes / Alerts
    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.
  • Extra notes in the data
    Report Source: NCMDR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Reason
    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

Stereotactic Circular Collimator
  • Model / 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 )
  • Product Description
    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
    Elekta Limited

Manufacturer

Elekta Limited
  • Manufacturer Parent Company (2017)
    Elekta AB
  • Manufacturers representative
    Analysis Device For Medical and Scientific Service ( ADMSS )
  • Source
    SFDA