Events

Device Recall Merge Eye Care PACS Viewer 5.2 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
    77627
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2754-2017
  • 사례 시작날짜
    2017-06-13
  • 사례 출판 날짜
    2017-07-10
  • 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=156932
  • 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 management, ophthalmic - Product Code NFJ
  • 원인
    When the user has not set up any user preference on the sorting order to render the study images (os/od/etc.) and reports, the ecp may get an incorrect study index. if the user attempts to delete an image, ecp may then read that image as os when it is, in fact, od.
  • 조치
    The firm initiated the recall by certified letter the week of 06/26/2017. The notice provided the work-around and requested a response.

Device

Device Recall Merge Eye Care PACS Viewer 5.2
  • 모델명 / 제조번호(시리얼번호)
    Version 5.2
  • 의료기기 분류등급
    Ophthalmic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    FL, IL, CO, MI, CA, NY, ND, OH, CT
  • 제품 설명
    Merge Eye Care PACS Viewer 5.2 || Merge Eye Care PACS is a software solution for the display, management, archive, interface and integration of ophthalmic device reports, images and data. || Merge Eye Care PACS is a software solution using databases for patient demographics, server and other systems of intercommunication with hospital systems via HL7 and DICOM to provide to clinicians a single image viewing and management solution of images imported from various contributing devices throughout the clinical environment. || Merge Eye Care PACS provides the ability to review data from any network-connected computer, and is protected by appropriate security login which permits only authorized user access. Symphony uses 256 bit or greater encryption via secure socket layer (SSL) to assure a network environment which is secure.
  • Manufacturer
    Merge Healthcare, Inc.

Manufacturer

Merge Healthcare, Inc.