BEUDAMED
    FDA Enforcement Class II Ongoing

    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 · Reported August 10, 2016

    Enforcement

    Recall Number
    Z-2255-2016
    Event ID
    74593
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Olympus Scientific Solutions Americas
    Voluntary / Mandated
    FDA Mandated
    Initial Notification
    Letter
    Report Date
    August 10, 2016
    Initiation Date
    June 22, 2016
    Classification Date
    July 29, 2016
    Address
    48 Woerd Ave, Waltham, MA, 02453-3824, United States

    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.

    Code Info

    All Models of the Delta XRF Analyzer with Software version 2.5.17.1 and higher

    Distribution

    Nationwide Distribution.

    Quantity

    2, 210 units distributed in the USA