BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-2760-2017 · Initiated July 11, 2017

    Recall

    Recall Number
    Z-2760-2017
    Event Number
    77759
    Firm
    Olympus Scientific Solutions Americas
    FEI Number
    3006241029
    Product Code
    RBY
    Status
    Terminated
    Root Cause
    Radiation Control for Health and Safety Act
    Initiated
    July 11, 2017
    Terminated
    May 3, 2023
    Address
    48 Woerd Ave, Waltham, MA, 02453-3824

    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).

    Action

    Olympus Scientific Solutions Americas Corp will bring defect into compliance: 1. Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. This office and the Food and Drug Administration (FDA) district office coordinator noted below are to be included in the notification. 2. Tracking of customer/owner self-installation(s) of the software update should be done to the maximum possible extent via serial-number-tracked downloads, follow-up email reporting, return- mail card or by other similarly effective means. For further questions, please call (781) 419-3900.

    Distribution

    Worldwide Distribution - USA (nationwide) Distribution

    Quantity

    146 units