Events

Recall of Device Recall Centricity TriWin Laboratory

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
    50201
  • Event Risk Class
    Class 2
  • Event Number
    Z-1397-2009
  • Event Initiated Date
    2008-11-17
  • Event Date Posted
    2009-05-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-09-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=74977
  • 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
    A software defect in the centricity lab (triwin) product may incorrectly link patient information to a wrong report. also, when viewing results in patient viewer, and a coagulation result is higher or lower than the linearity limit, then all of the results following the higher or lower result will show the same result as the first flagged result.
  • Action
    GE Healthcare notified their Centricity TriWin Laboratory customer via letter dated 11/17/08 of the software anomalies resulting in patient safety issues involving the patient information incorrectly being linked to a wrong report, and when viewing results in Patient Viewer, and a coagulation result is outside of a linearity limit, then all of the results following the out of linearity result will show the same result as the first flagged result. The user was informed that a software patch has been prepared to resolve the issues and will be installed on their system. Any questions were directed to GE Technical Support at 888-778-3375 or 905-479-1249, select option 1. The accounts was requested to complete the enclosed customer reply form, supplying the workstation software or build number, and fax it back to 905-305-0046 to schedule the software upgrade.

Device

Device Recall Centricity TriWin Laboratory
  • Model / Serial
    software version 7.3
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA and country of Canada.
  • Product Description
    Centricity TriWin Laboratory Information System; GE Healthcare Integrated IT Solutions, Barrington, IL 60010 || The Centricity TriWin Laboratory product is a laboratory information system. It 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.
  • 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