Events

Merge Cardio 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
    77124
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2123-2017
  • 사례 시작날짜
    2016-04-13
  • 사례 출판 날짜
    2017-05-22
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-07-17
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=154998
  • 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
    Fetal patient report was automatically pulling prior measurement data for a prior fetus since the fetal study is based on the mother's mrn, resulting in the wrong fetal measurements getting referenced.
  • 조치
    The recalling firm issued a "Medical Device Correction" letter dated 4/13/2016 via e-mail. The letter identified the affected product, issue involved, potential harm, a work around, as well as the actions to be performed by both the customer and firm. Merge Technical Support will contact customers to discuss the fix. Customers are to ensure that all users are provided the notice. If the affected product was further distributed, those customers should be identified and notified of the issue. A copy of the notice may be provided to those customers. If there are additional questions, customers can e-mail recall@merge.com.

Device

Merge Cardio software
  • 모델명 / 제조번호(시리얼번호)
    Versions 10.0, 10.0.1, 10.1, 10.1.1,10.1.1.1, and 10.1.2.
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Distributed to the states of AZ, CT, FL, GA, IL, IN, LA, MI, NY, NC, OH, OK, TX, and VT.
  • 제품 설명
    Merge Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI. || Intended to be used to acquire, store, print, transfer, and archive clinical information.
  • Manufacturer
    Merge Healthcare, Inc.

Manufacturer

Merge Healthcare, Inc.