BEUDAMED
    FDA Enforcement Class II Ongoing

    Brand Name: THOR Product Name: NovoTHOR Gen 3.0 Reg PRX Model/Catalog Number: S2186 Software Version: N/A Product Description: The NovoTHOR and NovoTHOR XL are intended to emit energy in the visible and IR spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary increase in local blood circulation, temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, muscle spasm, and temporary relaxation of muscles. Component: N/A

    Recall: Z-2419-2025 · Reported September 3, 2025

    Enforcement

    Recall Number
    Z-2419-2025
    Event ID
    97297
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    THOR Photomedicine Ltd
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 3, 2025
    Initiation Date
    July 24, 2025
    Classification Date
    August 22, 2025
    Address
    2 Anglo Office Park, Units 1 &; 67 White Lion Road, Amersham, N/A, United Kingdom

    Description

    Brand Name: THOR Product Name: NovoTHOR Gen 3.0 Reg PRX Model/Catalog Number: S2186 Software Version: N/A Product Description: The NovoTHOR and NovoTHOR XL are intended to emit energy in the visible and IR spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary increase in local blood circulation, temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, muscle spasm, and temporary relaxation of muscles. Component: N/A

    Reason

    The potential for a failed welded nut to shear off. When this occurs, the gas strut on one side of the device becomes detached from the canopy, making the canopy difficult to lift.

    Code Info

    Model/Catalog Number: S2186; UDI-DI: Serial numbers: 4005, 4062;

    Distribution

    Worldwide distribution: US (nationwide): AK, AZ, CA, CO, CT, FL, GA, HI, ID, IN, MA, MD, NC, ND, NJ, NV, NY, OR, PA, TX, UT, VA, WA, WI, WV; and OUS (International): Australia, United Kingdom, Austria, Ireland, Italy, Lithuania, Netherlands, Poland, Serbia, Slovakia, Spain.

    Quantity

    2 units (1 US, 1 OUS)