Device Recall Centricity Laboratory Core Lab; Versions 3.3, 4.0, 4.1 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
    64789
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1585-2013
  • 사례 시작날짜
    2012-11-20
  • 사례 출판 날짜
    2013-06-24
  • 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
    Calculator/data processing module, for clinical use. - Product Code JQP
  • 원인
    If environment variables micro_correct_msg_type and correct_msg_type are set to different values, in microbiology result entry when released results (final report released) are changed and the corrected result messages are edited on the free-text form, some of the originally entered panel free-text is lost. for this issue to occur the original result must be amended and the environmental variabl.
  • 조치
    GE Healthcare sent an Urgent Medical Device Correction letter dated November 20, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Software correction is available. Please contact your GE service representative to request or install this update. Please contact your GE Service Representative with any question regarding this issue. For other questions please contact GE Helpdesk. Help Desk: North America: 1-888-778-3375 Help Desk: Europe: + 44 1603 877595 Help Desk: Asia Pacific + 61 3 5327 4000

Device

  • 모델명 / 제조번호(시리얼번호)
    Software Versions 3.3, 4.0, and 4.1
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US Distribution including the states of OH, NY, GA, TX, TN and MN and the countries of Australia, Qatar and England
  • 제품 설명
    The Centricity Laboratory System is intended to be an information system designed to support the clinical and administrative activities associated with the provision and utilization of clinical laboratory services and facilities, e.g., the storing and delivering of analytical results. It is a specially designed data program application (software), which is supplied for installation in existing mainframe or decentralized computers or a computer network. This software system will not be the software directly used to run, steer, or control any specific laboratory analyzer or equipment. It is intended for use in laboratory facilities, including a central laboratory or in a multiple laboratory environment servicing satellite laboratories, reference laboratories, clinics, etc. Centricity Laboratory System is not intended for direct patient contact.
  • Manufacturer

Manufacturer

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