Device Recall Centricity Laboratory System

  • Model / Serial
    Software Versions: 3.3, 4.0, 4.1
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US including MN and Internationally to India, Australia, Canada, and England.
  • Product Description
    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. || The Centricity Laboratory System product is designed to facilitate the general clinical, anatomic pathology and cytology laboratory workflow such as order entry, results entry, instrument interfacing, results reporting and patient record retrieval. It integrates with other Hospital Information Systems (HIS) through HL7 interface by order entering and also report processing. The Centricity Laboratory System is intended to interface with various lab results. Centricity Laboratory System is intended to be used by laboratory technologists, technicians, analyst and other trained/site authorized system users
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    GE Healthcare It, 540 W Northwest Hwy, Barrington IL 60010-3051
  • Manufacturer Parent Company (2017)
  • Source
    USFDA