BEUDAMED
    FDA Recall Terminated

    Olympus Scientific Solutions Americas Corporation (OSSA) VANTA XRF Analyzer. Model Vanta VCR and Vanta VMR Analytical X-ray systems

    Recall: Z-1036-2017 · Initiated January 7, 2017

    Recall

    Recall Number
    Z-1036-2017
    Event Number
    76208
    Firm
    Olympus Scientific Solutions Americas
    FEI Number
    3006241029
    Product Code
    RBY
    Status
    Terminated
    Root Cause
    Radiation Control for Health and Safety Act
    Initiated
    January 7, 2017
    Terminated
    August 27, 2019
    Address
    48 Woerd Ave, Waltham, MA, 02453-3824

    Description

    Olympus Scientific Solutions Americas Corporation (OSSA) VANTA XRF Analyzer. Model Vanta VCR and Vanta VMR Analytical X-ray systems

    Reason

    It was discovered under rare circumstances the LED warning light circuit could fail. If this happens, while the instrument is emitting X-rays during at test, the LED warning lights will not illuminate. The test runs normally and will execute as before, but the light will not be on.

    Action

    Olympus will bring the defect 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 recall 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) 419-3500.

    Distribution

    US Distribution to the states of : PA, MA, CO, OH, NJ, GA, CA, TX, IL, VA, MN, NH, WA, SC, AZ, LA, MD, OK, IN, NY, NC and KS.

    Quantity

    US 74