Events

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

Saudi Food & Drug Authority에 따르면, 해당 translation missing: ko.activerecord.attributes.event.types.recall_field_safety_notice 는 Saudi Arabia 에서 Elekta Limited 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

현장 안전성 서한은 의료기기 제조사 또는 제조사 대리인이 시중에 유통되고 있는 자사 의료기기 제품에 대하여 취할 수 있는 조치를 알리는 소통방식입니다. 주요 대상층은 보건의료업계 종사자와 의료기기 사용자들입니다. 여기에는 회수(recall) 조치와 경고도 포함될 수 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall / Field Safety Notice
  • 사례 ID
    mdprc 182 07 13 001
  • 사례 시작날짜
    2013-11-05
  • 사례 국가
    Saudi Arabia
  • 사례 출처
    SFDA
  • 사례 출처 URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=4676
  • 비고 / 경고
    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.
  • 데이터 추가 비고
    Report Source: NCMDR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • 원인
    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
  • 모델명 / 제조번호(시리얼번호)
    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 )
  • 제품 설명
    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
  • 제조사 모회사 (2017)
    Elekta AB
  • 제조사 대표
    Analysis Device For Medical and Scientific Service ( ADMSS )
  • Source
    SFDA