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ONCOR IMPRESSION LINEAR ACCELERATOR. Anvisa Registry: 10234230126. 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Siemens 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
    958
  • 날짜
    2009-03-12
  • 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
    According to a communication letter sent to UTVIG / ANVISA by Siemens Ltda, the company will send a communication letter to its customers. The company also reported that equipment under risk in the country has not yet been installed, that is, they are not yet in operation. #### Update on 04/20/2012: According to communication sent on 04/17/2012, 2012 by the company for UTVIG / ANVISA (file no. 0324770128 of 04/19/12), the company has already closed the field action. The three equipments affected by the problem in Brazil were corrected by the company through a software update.
  • 원인
    The display of the equipment may be misaligned by about 4mm when compared to the reference image. with this, a single exposure image can be overwritten by a dual exposure image.
  • 조치
    The company that owns the product registration, Siemens Ltda, has not yet begun to communicate with users affected by this alert. According to the company, to avoid the possibility of overwritten images from a single exposure by a dual exposure image, users should acquire / load images of the same type of exposure during a session. If this recommendation is difficult to implement at the health facility, users are advised to select SAVE (save) to each image immediately after a modification. The ANVISA Technovigilance Unit (UTVIG / ANVISA) is monitoring this case.

Device

ONCOR IMPRESSION LINEAR ACCELERATOR. Anvisa Registry: 10234230126.
  • 모델명 / 제조번호(시리얼번호)
  • Manufacturer
    Siemens Ltda.

Manufacturer

Siemens Ltda.