Events

ELEKTA SOFTWARE FOR TREATMENT PLANNING. Models: MONACO and FOCAL. Anvisa Registry: 80569320003. (Update on 09/09/2014: Added FOCAL model) 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 IMPAC Medical Systems, Inc; Elekta Medical Systems Comércio e Serviços para Radioterapia Ltda. 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

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
    1412
  • 날짜
    2014-08-12
  • 사례 국가
    Brazil
  • 사례 출처
    ANVISA
  • 사례 출처 URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • 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
    As a consequence of the problem, the plan exported by the DICOM and the application of subsequent treatments would not correspond to the approved treatment plan. Thus, areas of the patient who should not receive doses may be treated and areas that should be treated may receive a dose that is higher or lower than the correct dose. According to the company's risk assessment, there is a remote possibility that the problem will lead to serious adverse health consequences.
  • 원인
    Incorrect handling when performing a dicom export of arcs using multiple field sequencing.
  • 조치
    The company is providing a software fix for the problem. To avoid adverse events, do not use 180 ° as the starting angle of the gantry of the second bow - using 180.1 ° or 179.9 ° as the initial gantry angle completely eliminates the problem. Users should follow the guidance given in the Important Field Safety Notice and confirm receipt of the notice for the local Elekta contact as soon as possible. The important Notice of Field Security disclosed by the company is available at: http://portal.anvisa.gov.br/wps/connect/d8e83d004513a40c9130d7004acc0eea/Messagem+de+Alerta+%282%29.pdf?MOD=AJPERES

Device

ELEKTA SOFTWARE FOR TREATMENT PLANNING. Models: MONACO and FOCAL. Anvisa Registry: 80569320003. (...

Manufacturer

IMPAC Medical Systems, Inc; Elekta Medical Systems Comércio e Serviços para Radioterapia Ltda.
  • 제조사 모회사 (2017)
    Elekta AB
  • Source
    ANVSANVISA