BEUDAMED
    FDA Enforcement Class II Ongoing

    OMTech Desktop Laser Engraver

    Recall: Z-2129-2024 · Reported June 19, 2024

    Enforcement

    Recall Number
    Z-2129-2024
    Event ID
    94785
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Rygel Advanced Machines d/b/a Omtech Laser
    Voluntary / Mandated
    FDA Mandated
    Initial Notification
    Letter
    Report Date
    June 19, 2024
    Initiation Date
    June 7, 2024
    Classification Date
    June 13, 2024
    Address
    1150 N Red Gum St, N/A, Anaheim, CA, 92806-2530, United States

    Description

    OMTech Desktop Laser Engraver

    Reason

    Lack of redundant interlocks, missing required labels and certification labels as required by 21 1010.2.

    Code Info

    Model: DF0812-40BG, USB-032B-U1

    Distribution

    US Nationwide

    Quantity

    641