BEUDAMED
    FDA Enforcement Class II Terminated

    Olympus Scientific Solutions Americas Corporation (OSSA) Model: VANTA Analytical X-Ray System, X-Ray Fluorescence

    Recall: Z-2760-2017 · Reported August 9, 2017

    Enforcement

    Recall Number
    Z-2760-2017
    Event ID
    77759
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Olympus Scientific Solutions Americas
    Voluntary / Mandated
    FDA Mandated
    Initial Notification
    Letter
    Report Date
    August 9, 2017
    Initiation Date
    July 11, 2017
    Classification Date
    August 2, 2017
    Termination Date
    May 3, 2023
    Address
    48 Woerd Ave, N/A, Waltham, MA, 02453-3824, United States

    Description

    Olympus Scientific Solutions Americas Corporation (OSSA) Model: VANTA Analytical X-Ray System, X-Ray Fluorescence

    Reason

    Instruments may, under certain specific circumstances listed below, fail to stop when a test is initiated and no sample is present (proximity shut down fails to end test).

    Code Info

    Models : VCR and VMR.

    Distribution

    Worldwide Distribution - USA (nationwide) Distribution

    Quantity

    146 units