Device Recall Centricity Laboratory Core Lab; Versions 3.3, 4.0, 4.1

  • 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
  • 1 Event

제조사

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