Events

LINEAR DIGITAL ARTISTE CELERATOR - 10234230172 - Risk class III. Serial Numbers: 10514 (Artiste syngo RT Therapist model) and 10321 (Artiste syngo RT Oncologist model). 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Siemens Ltda.; Siemens AG; Siemens Medical Solutions USA, Inc. 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
    1773
  • 날짜
    2015-12-18
  • 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
    The company Siemens informs that it is working to find a software solution to properly solve the problem described in the TH011 / 15 / S field action. Once the solution is available, the systems identified will be updated as soon as possible.
  • 원인
    The company reports a possible patient-related safety issue when using the adaptive targeting option in the syngo rt therapist and the syngo rt oncologist (versions 4.3.138, 4.3.Sp1, 4.3.1_ar1 or 4.3.1_mr2 ) in combination with multiple isocenters based on a planning ct. the described problem occurs if one or more treatment plans with at least 2 isocenters based on a planning ct are used and when a conical beam ct was acquired for each isocenter. the system supports the workflow correctly until the user makes a manual change to another isocenter. at this time, the overlapping images in adaptive targeting may be incorrect.
  • 조치
    The company recommends users and patients: Always use automatic registration after a manual change to another isocenter before using manual registration. Therefore, for all security measures, all affected customers should implement this recommendation and immediately inform all persons who may be involved in such a question. (Field Action Code TH011 / 15 / S)

Device

LINEAR DIGITAL ARTISTE CELERATOR - 10234230172 - Risk class III. Serial Numbers: 10514 (Artiste s...

Manufacturer

Siemens Ltda.; Siemens AG; Siemens Medical Solutions USA, Inc.