Device Recall nordicTumorEx 1.0 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 NordicNeuroLab AS 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    78460
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2042-2018
  • 사례 시작날짜
    2014-12-15
  • 사례 상황
    Open, Classified
  • 사례 국가
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    System, image processing, radiological - Product Code LLZ
  • 원인
    An error was discovered in the interpretation of certain dicom header tags that may lead to incorrect orientation labeling, and thus and indirect left-right, up-down or anterior-posterior flipping of images.
  • 조치
    The firm notified their consignees of the software problem by email on December 14, 2014. For further questions please call (262) 337-2909.

Device

  • 모델명 / 제조번호(시리얼번호)
    Version 1.0.4
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (nationwide) and to the countries of : SA, Russia, South Korea, UK, Japan, Australia, Sweden, Norway, Greece
  • 제품 설명
    nordicTumorEx 1.0 || nordicTumorEx is an image processing software package to be used by trained professionals including but not limited to physicians and medical technicians. The software runs on a standard off-the-shelf PC workstation and can be used to perform image viewing, processing and analysis of medical images. Data and images are acquired through DICOM compliant imaging devices and modalities. nordicTumorEx software enables processing and visualization of dynamic MR imaging datasets of the brain, showing properties of changes in contrast overtime. It generates various parametric images calculated from the image intensity variations and provides tools to extract and visualize such parametric properties within specified volumes of interest. Structural datasets providing anatomical information can be sued to evaluate the extent of a specified sub-volume, such as a tumor. Comparison of imaging studies performed at different study dates may also be performed to support the diagnostic process.
  • Manufacturer

Manufacturer

  • 제조사 주소
    NordicNeuroLab AS, Mollendalsveien 65c, Bergen Norway
  • 제조사 모회사 (2017)
  • Source
    USFDA