Events

Centricity Enterprise Archive 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 GE Healthcare Integrated IT Solutions 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
    52858
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2316-2009
  • 사례 시작날짜
    2009-08-14
  • 사례 출판 날짜
    2009-09-24
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-02-25
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=84174
  • 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
    Device, digital image storage, radiological - Product Code LMB
  • 원인
    Software error: there is potential safety issue with centricity enterprise archive (ea) 3.0.X software where study split operations are not correctly replicated to a secondary 'shadow' archive.
  • 조치
    GE Healthcare Integrated IT Solutions sent Urgent Medical Device Correction letters dated August 7, 2009 to the attention to the Director of Radiology, the Hospital Administrator, the Head of the Radiology Department and the PACS Administrator. The letters advised users of the potential safety issue and provided safety instructions to follow until the software is updated. Users were asked to complete the enclosed Customer Reply form and fax the completed form to 1-847-939-1479. Any questions should be directed to the Remote Online Center or the GE Customer Care Center at 1-800-437-1171.

Device

Centricity Enterprise Archive
  • 모델명 / 제조번호(시리얼번호)
    Software versions 3.0, 3.0.1, 3.0.2, 3.0.3, 3.0.4, 3.0.5, 3.0.6 and 3.0.7
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- United States, Belgium, Canada, Cayman Islands, China, Denmark, France, Germany, Great Britain, Hong Kong, India, Israel, Italy, Korea, Malaysia, Malta, Mexico, New Zealand, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan and Turkey.
  • 제품 설명
    Centricity Enterprise Archive (EA) versions 3.0 to 3.0.7 software; GE Healthcare Integrated IT Solutions, Barrington, IL 60010. || The software delivers a scalable and flexible DICOM storage solution for Cardiology and Radiology images.
  • Manufacturer
    GE Healthcare Integrated IT Solutions

Manufacturer

GE Healthcare Integrated IT Solutions
  • 제조사 주소
    GE Healthcare Integrated IT Solutions, 540 W Northwest Hwy, Barrington IL 60010-3051
  • Source
    USFDA