BEUDAMED
    FDA Enforcement Class II Ongoing

    NovoTHOR Gen 2.5 XL whole body red light therapy bed, model S2184.

    Recall: Z-0456-2024 · Reported December 13, 2023

    Enforcement

    Recall Number
    Z-0456-2024
    Event ID
    93344
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Thor Photomedicine Ltd
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    December 13, 2023
    Initiation Date
    September 13, 2022
    Classification Date
    December 1, 2023
    Address
    Watermeadow House, Chesham, N/A, United Kingdom

    Description

    NovoTHOR Gen 2.5 XL whole body red light therapy bed, model S2184.

    Reason

    Failure of ball stud components causing the gas strut on one side to detach from the canopy, making the canopy difficult to lift.

    Code Info

    Serial numbers: 3025, 3026, 3027, 3030, 3031, 3034, 3035, 3036, 3037, 3038, 3039, 3040, 3042, 3043, 3044, 3045, 3047, 3050, 3051, 3053.

    Distribution

    Worldwide Distribution: US (Nationwide): Arizona, California, Colorado, Connecticut, Florida, Hawaii, Idaho, Illinois, Iowa, Maryland, Michigan, Minnesota, Missouri, Nevada, New Hampshire, North Carolina, Ohio, Oregon, Texas, Utah, Virginia, West Virginia. OUS (foreign) to countries of: Australia, Canada, Netherlands, New Zealand, Singapore, United Kingdom.

    Quantity

    26