Events

Device Recall 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
    75714
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0730-2017
  • 사례 시작날짜
    2015-10-01
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2018-03-23
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=151092
  • 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
    Reporting feature times out after inactivity for more than an hour sending the user back to the study list, which causes all reporting data being entered to be lost.
  • 조치
    MERGE sent an Urgent Medical Device Recall letter dated March 28, 2016, to all affected customers. Non-responders were issued a second letter dated July 11, 2016, The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to reply using the enclosed form and the return addressed envelope and also to ensure that all users of the product were provided with the notification. If product was further distributed, customer were asked to identify their customers and notify them at once of the product recall. Customers with questions were advised to email recall@merge.com. For questions regarding this recall call 877-741-5369.

Device

Device Recall Merge Cardio software
  • 모델명 / 제조번호(시리얼번호)
    Versions V10.1 and 10.1.1
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution
  • 제품 설명
    Merge Cardio software. || Merge Cardio is a system intended to be used to acquire, store, print, transfer, and archive clinical information from Camtronics and other vendors systems including images, hemodynamic studies and reports, measurements (via import from DICOM Structured reporting, text files or optical character recognition of measurements captured on images) and cardiology signal (waveform) data
  • Manufacturer
    Merge Healthcare, Inc.

Manufacturer

Merge Healthcare, Inc.