BEUDAMED
    FDA Recall Terminated

    Hettich Centrifuge Modules: StreamLAB Centrifuge Module (10372372 or 10444807 or 10706836) Aptio Centrifuge Module (10703032 or 10713761) FlexLab High Throughput Centrifuge Module (11171747) FlexLab and Aptio Centrifuge Module (10628157 or 11266581): Used to separate substances according to their densities.

    Recall: Z-2087-2016 · Initiated May 11, 2016

    Recall

    Recall Number
    Z-2087-2016
    Event Number
    74280
    Firm
    Siemens Healthcare Diagnostics Inc.
    FEI Number
    3002755490
    Product Code
    LXG
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    May 11, 2016
    Terminated
    April 27, 2018
    Address
    101 Silvermine Rd, Brookfield, CT, 06804-2047

    Description

    Hettich Centrifuge Modules: StreamLAB Centrifuge Module (10372372 or 10444807 or 10706836) Aptio Centrifuge Module (10703032 or 10713761) FlexLab High Throughput Centrifuge Module (11171747) FlexLab and Aptio Centrifuge Module (10628157 or 11266581): Used to separate substances according to their densities.

    Reason

    Premature bucket failures

    Action

    Siemens mailed to customers an Urgent Medical Device Correction (UMDC#LAI16-02.A.US) Urgent Field Safety Notification letter informing customers of the problem with recommendations to follow the existing maintenance instructions in the product operator manuals as well as a new requirement to spin at cycle speeds not exceeding 3500 rpm.

    Distribution

    Nationwide: AL, AR, AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, PA, SC, SD, TN, TX, VA, WA, WI, WV.

    Quantity

    487