Events

DR Systems Unity PACS software, now known as Merge Unity PACS 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
    75876
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0939-2017
  • 사례 시작날짜
    2015-10-15
  • 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=151514
  • 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
    The software fails to associate to the correct mg image if there are two images for the same view.
  • 조치
    Merge sent an Urgent : Medical Device Recall letter dated July 11, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Be aware of the following workaround: Customer I User: Ensure both" tome" images are reviewed when more than one is captured for the same view. Merge has a released fix available for this issue. YOUR RESPONSE TO THIS NOTIFICATION IS REQUIRED Please reply using the enclosed form and the return addressed envelope. Your response is required no later than August 2,2016. For further questions regarding this recall please call (877) 741-5369

Device

DR Systems Unity PACS software, now known as Merge Unity PACS software.
  • 모델명 / 제조번호(시리얼번호)
    Version 11.0
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Distribution was made to medical facilities located in MT, CA, PA, and TX.
  • 제품 설명
    DR Systems Unity PACS software, now known as Merge Unity PACS software.
  • Manufacturer
    Merge Healthcare, Inc.

Manufacturer

Merge Healthcare, Inc.