Events

Merge Hemo 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
    76859
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1778-2017
  • 사례 시작날짜
    2016-04-04
  • 사례 출판 날짜
    2017-04-11
  • 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=154414
  • 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
    Computer, diagnostic, programmable - Product Code DQK
  • 원인
    Use of the software may show an incorrect value to the user when viewing the fractional flow reserve (ffr) results during recording.
  • 조치
    MERGE sent an Urgent Medical Device Recall letter dated April 4, 2016 to all affected customers via e-mail the week of April 4, 2016. If no email address was available, the letters were issued via certified mail. A second letter dated July 11, 2016 was issued to non-responders. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to ensure that all users of the affected product be provided with the notice. Customers were also asked to reply using the enclosed form and the return addressed envelope. Customers with questions were instructed to send an email to recall@merge.com. For questions regarding this recall call 877-741-5369.

Device

Merge Hemo software
  • 모델명 / 제조번호(시리얼번호)
    Versions 9.10.0, 9.20.0, 9.20.1, 9.20.2, 9.30.3, and 9.40.0.
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution including AZ, CA, CO, FL, GA, KS, LA, MI, MO, OH, OK, TN, TX, VA, WA, WI, and WV.
  • 제품 설명
    Merge Hemo software. The firm name on the labeling is Merge Healthcare, Hartland, WI. || Merge Hemo monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure
  • Manufacturer
    Merge Healthcare, Inc.

Manufacturer

Merge Healthcare, Inc.