Events

digital mammography system 의 안전성 경고

National Institute of Drugs and Food Surveillance (INVIMA)에 따르면, 해당 안전성 경고 는 Colombia 에서 Fujifilm techno products co, ltd || Fujifilm corporation 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
    I1708-361
  • 사례 연번
    2013EBC-0009847
  • 날짜
    2017-10-25
  • 사례 국가
    Colombia
  • 사례 출처
    INVIMA
  • 사례 출처 URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=67
  • 비고 / 경고
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 recall data from the U.S. and Colombia.
  • 데이터 추가 비고

Device

digital mammography system
  • 모델명 / 제조번호(시리얼번호)
    FDR-1000AWS, FDR-2000AWS, FDR-3000AWS, CR-IR363AWS
  • 제품 설명
    The FUJIFILM digital mammography system is indicated for obtaining digital radiographic mammographic images by means of low doses of rx in the following procedures but without being limited to them: screening mammograms: diagnostic explorations for early detection of breast cancer, in women who do not have symptoms. Diagnostic mammograms: revisions to assist in the diagnosis of mammary diseases and evaluation of abnormal clinical pictures of exploration mammograms in order to determine the cause of the controversial area in the exploration examination. Obtaining digital mammographic images, their processing, recording and post-production. of the mammographic images obtained for diagnostic purposes. Additionally, they can be used as a support for the stereotaxic guide or for three coordinates for the placement of mammary gland biopsy needles after the mammography, noting that this equipment or its accessories contain biopsy needles, only give the coordinates for its placement and allow its application in the exact place chosen by the doctor through the FUJIFILM digital mammography system guide
  • Manufacturer
    Fujifilm techno products co, ltd || Fujifilm corporation

Manufacturer

Fujifilm techno products co, ltd || Fujifilm corporation