BEUDAMED
    FDA Recall Terminated

    Altrix Precision Temperature Management System Model: 8001Product Usage: The Altrix system is intended for circulating temperature controlled warm or cold water via patient contact thermal transfer devices for the application of regulating human body temperature in situations where a physician or clinician with prescription privileges determines that temperature therapy is necessary or desirable.

    Recall: Z-0235-2019 · Initiated September 6, 2018

    Recall

    Recall Number
    Z-0235-2019
    Event Number
    81103
    Firm
    Stryker Medical Division of Stryker Corporation
    FEI Number
    1831750
    Product Code
    DWJ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    September 6, 2018
    Terminated
    April 13, 2020
    Address
    3800 E Centre Ave, Portage, MI, 49002-5826

    Description

    Altrix Precision Temperature Management System Model: 8001Product Usage: The Altrix system is intended for circulating temperature controlled warm or cold water via patient contact thermal transfer devices for the application of regulating human body temperature in situations where a physician or clinician with prescription privileges determines that temperature therapy is necessary or desirable.

    Reason

    Users may experience alarm fatigue due to frequent alarming relating to patient temperature deviation beyond 0.5C while in Automatic mode. 2. Users may experience a Remove from Use code 9 (RFU 9) fault condition relating to inadvertent flow alarms.3. Users may experience code RFU 27 fault condition relating to mechanical interference between the device fan and filter

    Action

    Stryker notified accounts by letter on 9/6/18 via Fed'X advising of the problem, steps to be taken: 1.Locate the units listed on the attached business reply form and identify the address where they can be serviced. 2.Return the enclosed business reply form to confirm receipt of this notification by fax 269 488 8691 or email [email protected]. 3.Upon receipt of the completed business reply form, Stryker will contact you to arrange for the modification/repair of your Altrix unit. 4.If you have questions regarding the safe continued use of your Altrix unit, please contact Tech Support by calling +1 800 327 0770 and selecting opt 2.

    Distribution

    Worldwide - US Nationwide Distribution and the countries of Foreign: Australia, Canada, Netherlands, Switzerland and United Kingdom

    Quantity

    389 units