BEUDAMED
    FDA Enforcement Class II Ongoing

    Fresh Roast Systems ColorTrack. Model Name: ColorTrack. Model Number: BENCH R-100

    Recall: Z-2280-2026 · Reported June 17, 2026

    Enforcement

    Recall Number
    Z-2280-2026
    Event ID
    99111
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Fresh Roast Systems Inc
    Voluntary / Mandated
    FDA Mandated
    Initial Notification
    N/A
    Report Date
    June 17, 2026
    Initiation Date
    April 15, 2026
    Classification Date
    June 11, 2026
    Address
    200 Ocean Lane Dr Apt 806, N/A, Key Biscayne, FL, 33149-1447, United States

    Description

    Fresh Roast Systems ColorTrack. Model Name: ColorTrack. Model Number: BENCH R-100

    Reason

    A defect has been identified in the manufacture of the Fresh Roast Systems ColorTrack instrument model number BENCH R-100 which could under very rare specific misuse circumstances potentially allow human access to infrared laser light levels in excess of the safety Classification of the product.

    Code Info

    Only Model Number provide. Model Number: BENCH R-100

    Distribution

    U.S.

    Quantity

    38