BEUDAMED
    FDA Recall Terminated

    TCM4 series Base Units, and spare part Power Supply, Radiometer Medical ApS, Akandevej 21, Brnshj, Denmark, www.radiometer.com. The devices are intended for continuous monitoring of carbon dioxide and oxygen partial pressures, oxygen saturation, and pulse rate.

    Recall: Z-1930-2013 · Initiated November 27, 2012

    Recall

    Recall Number
    Z-1930-2013
    Event Number
    65843
    Firm
    Radiometer America Inc
    FEI Number
    1523456
    Product Code
    LPP
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    November 27, 2012
    Posted
    August 8, 2013
    Terminated
    June 16, 2014
    Address
    810 Sharon Dr, Westlake, OH, 44145-1521

    Description

    TCM4 series Base Units, and spare part Power Supply, Radiometer Medical ApS, Akandevej 21, Brnshj, Denmark, www.radiometer.com. The devices are intended for continuous monitoring of carbon dioxide and oxygen partial pressures, oxygen saturation, and pulse rate.

    Reason

    RADIOMETER became aware that the TCM4 series Base Unit does not comply with IEC 60601-1 Sub Clause 15B.

    Action

    On 11/30/2012 the firm sent an "Urgent Field Safety Notice" to their customers. The notification explained the issue and provided recommended actions. Customers may contact 1-800-736-0600 option 4 with questions.

    Distribution

    Worldwide distribution: US (nationwide) AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, TX, UT, VA, VT, WA, WI, WV & WY; and country of: Canada.

    Quantity

    5,874 units