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 Nucletron bv 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 088 05 11 000
  • 사례 시작날짜
    2011-05-29
  • 사례 국가
    Saudi Arabia
  • 사례 출처
    SFDA
  • 사례 출처 URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=5&rid=450
  • 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: NCAR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • 원인
    Investigation by the manufacturer showed that in the service mode the “source alignment procedure” could be started with the door physically open. the door interlock only triggers if the door is closed prior to alignment. the alignment can also be done with the doorswitch on linac . if set to linac , the door interlock to the hdr will always be seen by flexitron as being open. in the source alignment mode of the flexitron, the firmware does not look at the state of the door interlock but only to the state-change ( from closed to open). in this case the ir192 –source was thus not automatically retracted into the vault of the apparatus when opening the door of the irradiation bunker as the door switch only works in clinical mode.

Device

FLEXITRON HDR 40 CH(Diagnostic and therapeutic radiation device)
  • 모델명 / 제조번호(시리얼번호)
    Software version: TDU (Treatment Delivery Unit): v 1.1.0 TCC ( Treatment Communication console ) : 1.2.1 Serial No: SYS00003
  • 제품 설명
    Brachy therapy after loader, The Flexitron Remote After loader System enables an operator to remotely apply a radionuclide source (Ir192) into the body or to the surface of the body for radiation therapy. The Flexitron system is intended to be used in combination with applicators which make it suitable for intracavitary, interstitial,intralumenary, bronchial, endovascular, intra-operative and surface brachytherapy.
  • Manufacturer
    Nucletron bv

Manufacturer

Nucletron bv