BEUDAMED
    FDA Enforcement Class II Terminated

    Draeger Infinity Acute Care System Monitoring Solution

    Recall: Z-0714-2014 · Reported January 22, 2014

    Enforcement

    Recall Number
    Z-0714-2014
    Event ID
    67056
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Draeger Medical Systems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 22, 2014
    Initiation Date
    December 10, 2013
    Classification Date
    January 10, 2014
    Termination Date
    May 20, 2015
    Address
    3135 Quarry Rd, Telford, PA, 18969-1042, United States

    Description

    Draeger Infinity Acute Care System Monitoring Solution

    Reason

    After a test in which a low SpO2 (yellow) medium grade alarm initiated in neo-natal mode and was subsequently paused, the high grade life threatening SpO2 alarm (red) did not activate when the SpO2 values were decreased to reach the red alarm limit.

    Code Info

    with software versions VG2.0.3 and higher.

    Distribution

    US Distribution including the states of: MA, NH, IN, CA, TX, NY, OK, and IL.

    Quantity

    439