Events

Merge LIS 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
    77299
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2628-2017
  • 사례 시작날짜
    2016-04-15
  • 사례 출판 날짜
    2017-05-25
  • 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=155647
  • 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
    Calculator/data processing module, for clinical use - Product Code JQP
  • 원인
    There are potential issues with results reporting for certain run-based tests. under certain conditions, the wrong results could inadvertently be verified.
  • 조치
    Merge Healthcare issued a letter dated April 15, 2017, via email or via certified mail if they did not have an email address for the customer. The letter notifies the customer of the issue, informs them of a workaround, and lets them know a fix is being planned and they will be notified once it is made available. The notification instructs the customer to pass the information onto all other users, as well as any downstream customers if it was further distributed. The notification also informs the customer their response is required using the enclosed form and the return addressed envelope. The response form asks, in part, if they are interested in accepting the fix. If they decline the fix, they are asked to provide the reason why. The response was required no later than April 29, 2016. For further questions, call (877) 741-5369.

Device

Merge LIS
  • 모델명 / 제조번호(시리얼번호)
    Versions V3.7, 3.7.1, 3.7.2, 3.7.3, 3.8, 3.8.0.1, 3.8.1, 3.8.2, 3.9.1, 3.9.2, 3.9.3, 4.1, 4.1.1, 4.1.2, 4.1.3, and 4.1.4
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution to facilities and distributors. Distribution was made to the Virgin Islands. Foreign distribution was also made. There was no military/government distribution.
  • 제품 설명
    Merge LIS software. The firm name on the label is Merge Healthcare. || Merge LIS system is a complete system for ordering, managing and reporting a patient s laboratory work, from the time of order entry to the time the laboratory test results are reported.
  • Manufacturer
    Merge Healthcare, Inc.

Manufacturer

Merge Healthcare, Inc.