BEUDAMED
    FDA Recall Terminated

    Draeger Infinity Acute Care System Monitoring Solution

    Recall: Z-0714-2014 · Initiated December 10, 2013

    Recall

    Recall Number
    Z-0714-2014
    Event Number
    67056
    Firm
    Draeger Medical Systems, Inc.
    FEI Number
    2510954
    Product Code
    MHX
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    December 10, 2013
    Posted
    January 10, 2014
    Terminated
    May 20, 2015
    Address
    3135 Quarry Rd, Telford, PA, 18969-1042

    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.

    Action

    An Urgent Medical Device Recall Letter, dated December 2013, was sent to Users. Once available Drager will update components of the IACS Monitoring Solution System.

    Distribution

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

    Quantity

    439