Events

Recall of Device Recall Centricity Laboratory System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by GE Healthcare It.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    64807
  • Event Risk Class
    Class 2
  • Event Number
    Z-0620-2014
  • Event Initiated Date
    2013-03-12
  • Event Date Posted
    2014-01-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-06-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117106
  • Notes / Alerts
    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.
  • Extra notes in the data
    Calculator/data processing module, for clinical use - Product Code JQP
  • Reason
    Ge healthcare is aware of a potential safety issue with the use of ge centricity laboratory instrument interface (if) where free-text sent from im is not being transcribed into free-text in inet. the instrument may upload results to if/inet when order/request is not yet in if/inet. in such a situation, test level supporting free-text sent from the instrument is discarded (not captured).
  • Action
    GE Healthcare sent an URGENT MEDICAL DEVICE CORRECTION letter dated March 12, 2013 to all affected customers. The letter notified customers of the problem, suggested that customers experiencing this problem should retransmit the result from the instrument once the order exists in iNET and verify that the item level free-text is present in iNET, and to contact their GE service representative to request or install the updated software. Customers with additional questions can contact the GE Healthcare IT Help Desk at 1-847-589-8496 or tgg.nahelpdesk@med.ge.com. For questions regarding this recall call 847-589-8496.

Device

Device Recall Centricity Laboratory System
  • Model / Serial
    Software Versions: 3.3, 4.0, 4.1
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • 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
    GE Healthcare It

Manufacturer

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