BEUDAMED
    FDA Recall Open, Classified

    Siemens Aptio Automation Centrifuge Module, tube loading algorithm, Inpeco SA P/N: FLX-202, with Firmware Versions: CM_1-7-0.H86 or xCMd_2-5-0.elf and CM_1-7-1.H86 or xCMd_2-5-1-849fad9.elf

    Recall: Z-1889-2020 · Initiated April 7, 2020

    Recall

    Recall Number
    Z-1889-2020
    Event Number
    85429
    Firm
    Inpeco S.A. Via San Gottardo 10 Lugano Switzerland
    FEI Number
    3010825766
    Product Code
    JJE
    Status
    Open, Classified
    Root Cause
    Software design (manufacturing process)
    Initiated
    April 7, 2020

    Description

    Siemens Aptio Automation Centrifuge Module, tube loading algorithm, Inpeco SA P/N: FLX-202, with Firmware Versions: CM_1-7-0.H86 or xCMd_2-5-0.elf and CM_1-7-1.H86 or xCMd_2-5-1-849fad9.elf

    Reason

    The FlexLab Centrifuge Module loading algorithm may lead to unbalanced loads which could damage the centrifuge.

    Action

    The firm sent an Urgent Medical Device Correction letter to all affected customers on March 30, 2020. The letter instructed the customers to complete and return the Customer Letter Receipt Confirmation and Implementation Check form. The firm explained that their regular service provider will contact them to schedule the firmware version upgrade.

    Distribution

    Worldwide distribution including the following states: Ohio, New York, Virginia, Pennsylvania, Texas, Delaware, California, Florida, Kentucky, Tennessee, Maryland, Rhode Island, Alabama, Massachusetts, Connecticut, Minnesota, Alabama, Montana, Louisiana, New Jersey, Virginia, New Hampshire, Michigan, North Carolina, Washington, Iowa, New Mexico, Nebraska, and Missouri

    Quantity

    313