Three-dimensional Planning System for Eclipse Radiotherapy, model eclipse versions 11; 13.0; 13.5 and 13.6, registration 10405410007, risk class III, various series. 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Varian Medical Systems Brasil Ltda.; Varian Medical Systems. 에 의해 제조된 제품과 관련되어 있습니다.

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안전성 경고는 의료기기 제품과 관련된 중요한 정보와 권고사항을 담고 있습니다. 물론 안전성 경고가 배포되었다고 해서 해당 제품이 무조건 안전하지 않은 제품이라는 것은 아닙니다. 보건의료업계 종사자와 의료기기 사용자들에게 배포되는 안전성 경고에는 회수(recall)도 포함될 수 있습니다. 제조사가 안전성 경고를 작성하기도 하지만, 보건당국에서 작성하는 경우도 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert
  • 사례 ID
    1822
  • 날짜
    2016-02-04
  • 사례 국가
  • 사례 출처
    ANVISA
  • 사례 출처 URL
  • 비고 / 경고
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 data from the U.S. and Brazil.
  • 데이터 추가 비고
    Recommendations for users and patients: DO NOT USE Eclipse versions 11, 13, 13.5 or 13.6 with the PBC 11.0.31 algorithm for conventional arc field dose calculation. #### UPDATED ON 10/25/2017, the company submitted completion report of the field action proving the accomplishment of correction as planned.
  • 원인
    An anomaly was identified with the eclipse three-dimensional planning system using pbc 11.0.31 to calculate a conventional arcuate dose distribution. when using pbc 11.0.31 to calculate the dose for a conventional arc field with more than 100 segments with eclipse versions 11.0, 13.0, 13.5 or 13.6, the displayed dose does not correspond to the monitor units ( mu) calculated. potential for unintentional radiation exposure.
  • 조치
    Action code CP-23187. Varian Medical Systems Brazil has sent a Letter of Safety dated January 11, 2016 to all affected customers. The letter describes affected models, problem and necessary actions, among them the software update. For customer questions related to this help desk action of Varian Telephone: + 1-888-827-4265; E-mail: support@varian.com

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