BEUDAMED
    FDA Recall Terminated

    GE Healthcare Centricity Perinatal (formerly QS) System - PFILS (Patient File Server) software; automatic patient data management providing clinical information at the bedside in Labor & Delivery, Mother-Baby and the Neonatal Intensive Care Unit.

    Recall: Z-2037-2008 · Initiated June 30, 2008

    Recall

    Recall Number
    Z-2037-2008
    Event Number
    48755
    Firm
    GE Healthcare Integrated IT Solutions
    FEI Number
    3004526608
    Product Code
    HGM
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    June 30, 2008
    Posted
    July 30, 2008
    Terminated
    September 6, 2010
    Address
    540 W Northwest Hwy, Barrington, IL, 60010-3051

    Description

    GE Healthcare Centricity Perinatal (formerly QS) System - PFILS (Patient File Server) software; automatic patient data management providing clinical information at the bedside in Labor & Delivery, Mother-Baby and the Neonatal Intensive Care Unit.

    Reason

    Patient information mix-up: When the PFILS application, configured with a backup server has experienced a network interruption, PFILS verify could result in the Centricity Perinatal application recording non-identifiable patient information to the incorrect patient file.

    Action

    GE Healthcare notified their Centricity Perinatal customers via letter dated 7/20/07 of the problem with the PFILS application that could result in the Centricity Perinatal application recording non-identifiable patient information to the incorrect patient file. The letter provided the users with a workaround and provided them with a Frequently Asked Questions document which listed the availability of a software patch to fix the problem. A follow-up letter dated 6/27/08 was sent on 6/30-7/2/08 to those accounts who had not requested a PFILS Hotfix CD-ROM or had not had their software recently upgraded. The letter a copy of the 7/20/07 letter, the most recent FAQ, the PFILS Hotfix CD (PFIL67_66) and Installation Procedure for the PFILS Patch instructions for installation of the software patch. The accounts were advised that they can request an analysis of existing patient records to determine whether they have been affected by the PFILS issue, by submitting a non-critical Technical Support Request on the GE Centricity Perinatal Web site: http://www.gehealthcare.com/usen/security/cis/stupgrades.html, indicating "PFILS ANALYSIS REQUEST" in the Description of Issue field. Any questions were directed to Technical Support at 800-433-2009.

    Distribution

    Worldwide: USA, Puerto Rico, Canada, and China.

    Quantity

    1,031 units