Events

Recall of GE Centricity Ultra Laboratory System

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

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
    49517
  • Event Risk Class
    Class 2
  • Event Number
    Z-0472-2009
  • Event Initiated Date
    2008-09-22
  • Event Date Posted
    2008-12-31
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-05-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73713
  • 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
    Software computer, error: the abnormal result flag is not being sent in the hl7 messages on results that are lower than the normal range. for further information, please telephone ge healthcare integrated it solutions at 800-437-1171.
  • Action
    GE Healthcare notified their Centricity Ultra Laboratory Information System customers via letter dated 9/19/08. The letter was entitled "PRODUCT SAFETY NOTIFICATION." The letter states that the software correction was installed or will be installed to correct the abnormal results flag not being sent in the HL7 on results that are lower than the normal range. The letter summarized the safety concern and the action taken. Any questions were directed to GE Technical Support at 888-778-3373 or 905-479-1249. The accounts were requested to complete the enclosed customer reply form, supplying the software version number, and fax it back to 847-277-5240.

Device

GE Centricity Ultra Laboratory System
  • Model / Serial
    Software versions 3.3.2.27_P4 and 4.0.1_SP.x
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Globally - United States including the states of New York and Texas; and the country of Canada.
  • Product Description
    GE Centricity Ultra Laboratory System Software; for recording, reporting and distribution of lab results. GE Healthcare Integrated IT Solutions, Barrington, IL 60010.
  • Manufacturer
    GE Healthcare Integrated IT Solutions

Manufacturer

GE Healthcare Integrated IT Solutions
  • Manufacturer Address
    GE Healthcare Integrated IT Solutions, 540 W Northwest Hwy, Barrington IL 60010-3051
  • Source
    USFDA