Events

digital mammography system AMULET 의 안전성 경고

National Institute of Drugs and Food Surveillance (INVIMA)에 따르면, 해당 안전성 경고 는 Colombia 에서 manufacturer #121 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
    I1409-371
  • 사례 연번
    2013EBC-0009847
  • 날짜
    2014-09-17
  • 사례 국가
    Colombia
  • 사례 출처
    INVIMA
  • 사례 출처 URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=196
  • 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
  • 원인
    The manufacturer reports that it has detected a possible failure in the compression tray which after the capture of an instant breast has been blocked and does not allow the decompression for the normal withdrawal of the patient, which may lead to the occurrence of potentially adverse events on the patient .

Device

digital mammography system AMULET
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    The FUJIFILM digital mammography system is indicated for obtaining radiographic digital mammographic images by means of low doses of RX in the following procedures, but not limited to: screening mammograms: diagnostic tests 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 charts of screening mammograms in order to determine the cause of the controversial area in screening examination. Obtaining of digital mammographic images, their processing, recording and post-production of the mammographic images obtained with diagnostic purposes. Additionally, they can be used as a support for the stereotactic guide or for three coordinates for the placement of mammary gland biopsy needles after the mammography, noting that this equipment or its accessories do not contain biopsy needles, only give the coordinates for their placement and allow their application in the exact place chosen. by the doctor through the guide of the FUJIFILM digital mammography system.
  • Manufacturer
    manufacturer #121

Manufacturer

manufacturer #121
  • 제조사 모회사 (2017)
    Abbott Laboratories
  • 제조사 의견
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    NIDFSINVIMA