BEUDAMED
    FDA Recall Terminated

    Centricity Perinatal (formerly Quantitative Sentinel) System - Fluid Total Precision software; automatic patient data management providing clinical information at the bedside in Labor & Delivery, Mother-Baby and the Neonatal Intensive Care Unit; GE Healthcare Integrated IT Solutions, Barrington, IL 60010

    Recall: Z-0112-2009 · Initiated September 25, 2008

    Recall

    Recall Number
    Z-0112-2009
    Event Number
    49459
    Firm
    GE Healthcare Integrated IT Solutions
    FEI Number
    3004526608
    Product Code
    HGM
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    September 25, 2008
    Posted
    October 15, 2008
    Terminated
    May 17, 2010
    Address
    540 W Northwest Hwy, Barrington, IL, 60010-3051

    Description

    Centricity Perinatal (formerly Quantitative Sentinel) System - Fluid Total Precision software; automatic patient data management providing clinical information at the bedside in Labor & Delivery, Mother-Baby and the Neonatal Intensive Care Unit; GE Healthcare Integrated IT Solutions, Barrington, IL 60010

    Reason

    On the I&O chart, the IN, OUT and NET fluid totals values will not honor the numeric precision configuration, always displaying a whole number, losing decimal point accuracy.

    Action

    GE Healthcare notified their Centricity Perinatal customers via letter dated 4/20/07 of the problem with the Fluid I & O Module when fluid precision is required. The letter instructed those accounts that require fluid precision to contact GE Technical Support at 1-800-433-2009 to obtain a software patch to fix the problem. A follow-up letter dated 8/29/08 was sent on the same date to the accounts informing them that GE had re-classified the issue as a class II safety issue and that all customers need to have their software updated. The accounts were requested to contact GE Tech Support at 800-433-2009 to schedule a time to upgrade their system to 6.70.6 P02 as soon as possible. The accounts were requested to complete the enclosed customer reply form, supplying the workstation software or build number, and fax it back to 847-277-5240.

    Distribution

    Worldwide Distribution --- including USA and country of Canada.

    Quantity

    470 units