BEUDAMED
    FDA Recall Open, Classified

    Olympus Scientific Solutions Americas Corporation (OSSA) Model: Analytical X-Ray System X -Ray Fluorescence. Intended to emit ionizing radiation Delta with models: DC-2000, DC-4000, DC-6000, DI-2000, DP-2000, DP-4000, DP-4050, DP- 6000, DPO-4000, DPO-6000, DS-2000, DS-4000, DS-6000, DS-6500, Delta, Delta 50, Delta Classic Plus, Delta Element, Delta Premium , Delta Professional , and Delta-Pl us.

    Recall: Z-2255-2016 · Initiated June 22, 2016

    Recall

    Recall Number
    Z-2255-2016
    Event Number
    74593
    Firm
    Olympus Scientific Solutions Americas
    FEI Number
    3006241029
    Product Code
    RBY
    Status
    Open, Classified
    Root Cause
    Radiation Control for Health and Safety Act
    Initiated
    June 22, 2016
    Address
    48 Woerd Ave, Waltham, MA, 02453-3824

    Description

    Olympus Scientific Solutions Americas Corporation (OSSA) Model: Analytical X-Ray System X -Ray Fluorescence. Intended to emit ionizing radiation Delta with models: DC-2000, DC-4000, DC-6000, DI-2000, DP-2000, DP-4000, DP-4050, DP- 6000, DPO-4000, DPO-6000, DS-2000, DS-4000, DS-6000, DS-6500, Delta, Delta 50, Delta Classic Plus, Delta Element, Delta Premium , Delta Professional , and Delta-Pl us.

    Reason

    Trigger lock option does not always prevent x-ray generation. Specifically if the unit is in test mode or repeat test mode then the trigger lock may not prevent x-ray initiation when the trigger is pulled. The correction is via repair by a software update.

    Action

    The firm notified customers via an "Important - Electronic Product Radiation Warning" letter. It described the issue; and, told customers to not rely on the Trigger Lock feature until the software upgrade had been completed. The letter also provided instructions for customers to not only determine their software version; but, also instructions to bring their affected device into compliance. The firm will remedy the issue without charge. Customers can contact their local representative or OSSA at [email protected], phone: +1 866 446 6689, fax: +1 781 419 3980, with questions or if additional information is needed.

    Distribution

    Nationwide Distribution.

    Quantity

    2, 210 units distributed in the USA