GE Centricity PACS (Versions 3.1.1.2 or later) 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Ge Healthcare It 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
    64724
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0731-2014
  • 사례 시작날짜
    2012-09-15
  • 사례 출판 날짜
    2014-01-14
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2016-06-10
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 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
    There is a potential loss of image(s) associated with the centricity to centricity (c2c) exam transfer module of centricity pacs system versions 3.X and higher and 4.X and higher when transferring from the source to a destination server. when another process in the destination server attempts to access the same object or table, the transfer process of a particular image may be terminated. once ter.
  • 조치
    GE Healthcare sent an Important Product Information letter dated September 15, 2012 to affected customers. The letter identified the affected product problem and actions to be taken. GE Healthcare will provide a patch to 3.2.X and 4.0 Systems to remediate the issue. For questions contact your local GEHC-IT service representative.

Device

  • 모델명 / 제조번호(시리얼번호)
    GE Centricity Software versions 3.X and higher and 4.X and higher
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US: Nationwide (AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WV, WY); FOREIGN: Australia, Austria, Belgium, Bermuda, China, Denmark, Egypt, France, Germany, Hong Kong, India, Ireland, Israel, Italy, Japan, Korea, Kuwait, Malaysia, Malta, Netherlands, Portugal, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom.
  • 제품 설명
    Centricity PACS System versions 3.X and higher and 4.X and higher || Product Usage: The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals, including radiologists, physicians, technologists, clinicians and nurses. It is also intended for use as a clinical review workstation throughout the healthcare facility. the workstation interface provides the user with a means to display, manipulate, archive, print, and export images when connected with the Centricity PACS infrastructure.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Ge Healthcare It, 540 W Northwest Hwy, Barrington IL 60010-3051
  • 제조사 모회사 (2017)
  • Source
    USFDA