Events

CADstream software 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Merge Healthcare, Inc. 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
    75161
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0118-2017
  • 사례 시작날짜
    2011-10-19
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149492
  • 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
    Customers may experience an issue with the software study preferences when changes are made to the study protocol, resulting in incorrect patient follow-up.
  • 조치
    Merge sent an Urgent Medical Device Recall dated January 28, 2016 to affected customers via email and certified mail if no email address was available. The letter identified the affected product, problem and actions to be taken. For questions Customer Service at 877-741-5369 or support@merge.com.

Device

CADstream software
  • 모델명 / 제조번호(시리얼번호)
    Versions prior to 5.2.6
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Nationwide Distribution
  • 제품 설명
    CADstream software || Product Usage: || CADstream is an image processing system designed to assist in the visualization, analysis, and reporting of magnetic resonance imaging (MRI) studies. CADstream also is intended to provide workflow efficiency and interventional planning tools.
  • Manufacturer
    Merge Healthcare, Inc.

Manufacturer

Merge Healthcare, Inc.