Events

eFilm Workstation 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
    75270
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0707-2017
  • 사례 시작날짜
    2016-10-20
  • 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=149867
  • 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
    A product issues happens for rf projection images. if user measures on rf image, .Cal (calibration) is not displayed and measurement is not correct. the .Cal label is not displayed on the projection images after calibration is performed which should be present if the measurement is presented based on pixel spacing.
  • 조치
    Merge Healthcare sent an Urgent Medical Device Recall letter dated October 12, 2016, to all affected consignees. The letter described the Product, Issue, Potential Harm, Containment by the Customer / User, Actions by Merge, and Actions by Customers. Advised consignees to discontinue using the product, and identify & notify all customers. Requested consignees for a response to the notification. Customers with questions were instructed to send an email to recall@merge.com.

Device

eFilm Workstation
  • 모델명 / 제조번호(시리얼번호)
    EFilm Workstation and eFilm Lite versions 2.1, 2.1.2, 3.0, 3.1, 3.3.5, 3.4, 4.0, 4.0.1, 4.0.2, 4.0.3 and 4.1.
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US: Nationwide including DC, GU, PR and Internationally to Canada, Argentina, Armenia, Australia, Austria, Belgium, Brazil, Chile, China, Colombia, Congo, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Estonia, Finland, France, Germany, Greece, Guatemala, hong Kong, Hungary, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Kazakhstan, Latvia, Lebanon, Lithuania, Luxembourg, Malaysia, Mauritania, Mexico, Netherlands, New Caledonia, New Zealand, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Serbia and Montenegro, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Vietnam, and Yemen.
  • 제품 설명
    Merge, eFilm Workstation and eFilm Lite || eFilm Workstation with Modules is a software application that is used for viewing medical images. eFilm Workstation with Modules receives digital images and data from various sources (including but not limited to CT, MR, US, RF units, computed and direct radiographic devices, secondary capture devices, scanners, imaging gateways or imaging sources). eFilm Workstation with Modules can be used to communicate, process and display medical images. Users have access to various image processing and measurement tools to assist them in viewing images. In addition, users can overlay templates on medical images to aid in preoperative planning. eFilm Workstation with Modules can be integrated with an institution s existing HIS or RIS for a fully integrated electronic patient record. Typical users of eFilm Workstation with Modules are trained medical professionals, including but not limited to radiologists, technologists and clinicians
  • Manufacturer
    Merge Healthcare, Inc.

Manufacturer

Merge Healthcare, Inc.