Events

Trade Name: DIGITAL ARTISTE LINEAR ACCELERATOR. ANVISA registration No. 10234230172. Risk class III. List of lots / series: 10587; 10852. 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Siemens Healthcare Diagnósticos S.A Endereço; 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
    1888
  • 날짜
    2016-04-20
  • 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
    Recommendation to users and patients: Add a manual pause between the treatment fields if you want the system to stop / pause the treatment to move the table and the gantry manually.
  • 원인
    Siemens healthcare diagnostics sa has identified a problem due to the change of syngo rt therapist software in combination with the isocentric table rotations. there are two situations where the problem may occur: situation 1: when the "automatic movement" is configured a certain message will not be displayed, no pause will be added resulting in the automatic movement of all the programmed positions. situation 2: when "manual movement" is configured, the pause will not be added automatically and in this case the gantry can move before the table movement is performed.
  • 조치
    The Siemens-initiated field action code TH001 / 16 / S deals with a Risk Letter III Customer Submission (situation in which there is a low probability that the use or exposure to a health product may have adverse health consequences ). Recommendation to users and patients: Add a manual pause between the treatment fields if you want the system to stop / pause the treatment to move the table and the gantry manually.

Device

Trade Name: DIGITAL ARTISTE LINEAR ACCELERATOR. ANVISA registration No. 10234230172. Risk class I...

Manufacturer

Siemens Healthcare Diagnósticos S.A Endereço; Siemens Medical Solutions USA Inc.