BEUDAMED
    FDA Recall Terminated

    Olympus Scientific Solutions Americas Corporation ( OSSA ) Delta XRF Analyzer . This is a Analytical X-ray system

    Recall: Z-0803-2016 · Initiated January 13, 2016

    Recall

    Recall Number
    Z-0803-2016
    Event Number
    73251
    Firm
    Olympus Scientific Solutions Americas
    FEI Number
    3006241029
    Product Code
    RBY
    Status
    Terminated
    Root Cause
    Radiation Control for Health and Safety Act
    Initiated
    January 13, 2016
    Terminated
    May 18, 2021
    Address
    48 Woerd Ave, Waltham, MA, 02453-3824

    Description

    Olympus Scientific Solutions Americas Corporation ( OSSA ) Delta XRF Analyzer . This is a Analytical X-ray system

    Reason

    The Firm has discovered a Software bug.

    Action

    Olympus Scientific Solutions Americas ( OSSSA) planned action to bring product into compliance: Notification will be given to purchasers per 21 CFR 1003.21. A software modification will be made available to all users contacted. The letter to affected purchasers makes clear that the product will be brought into compliance without charge and offers the purchaser several options for applying the software update. CDRH approves the CAP subject to the following conditions: 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- controlled downloads, follow-up email reporting, return-mail card or some other similarly effective means. For further questions you may call : (866) 446-6689.

    Distribution

    Worldwide Distribution - USA (nationwide) Distribution

    Quantity

    US - 5000 units