Events

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

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
    64796
  • Event Risk Class
    Class 2
  • Event Number
    Z-2671-2016
  • Event Initiated Date
    2012-11-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-12-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117092
  • 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
    The centricity laboratory removes free-text notes on a master panel when the user deletes the slave panel. the deletion of a slave panel will (auto slash) the corresponding test (item) results on the master panel. additionally, the displayed and hl7 results show neither the appropriate abnormal flag value nor the reference range values, when using large_num.G >7 to report numeric results.
  • Action
    GE Healthcare, sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated Nov 20, 2012 to all affected customers. The letter described the product, problems and actions to be taken. The customers were instructed to follow the safety instructions and to ensure that all potential users in their facility are made aware of this safety notification and the recommended actions. The software has been modified to correct these defects. The modified software will be released and installed in user sites through GE Healthcare FMI #86071. Customers were instructed to contact their GE Service Representative with any questions regarding this issue. For other questions, contact GE Helpdesk: North America; (905) 479-1249 or 1-888-778-3375; email: tgg.nahelpdesk@med.ge.com Europe; +44 1603 877595; email: tgg.ukhelpdesk@med.ge.com Asia Pacific; +61 3 5327 4000; email: tgg.ozhelpdesk@med.ge.com. For questions regarding this recall call 847-277-5000.

Device

Device Recall Centricity Laboratory Core Lab Versions 3.3, 4.0, 4.1
  • Model / Serial
    Versions 4.1, 4.0, 3.3.2 & 3.3Almp
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Distribution to GA, OH, NY, TX, TN ,MN and Internationally to India, Australia, Canada, England, Qatar, and Scotland.
  • Product Description
    Centricity Laboratory Core Lab System 4.1 || 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.
  • 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