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

  • Modèle / numéro de série
    Software Versions 3.3, 4.0, and 4.1
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US Distribution including the states of OH, NY, GA, TX, TN and MN and the countries of Australia, Qatar and England
  • Description du dispositif
    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

Fabricant

  • Adresse du fabricant
    GE Healthcare It, 540 W Northwest Hwy, Barrington IL 60010-3051
  • Société-mère du fabricant (2017)
  • Source
    USFDA