BEUDAMED
    FDA Recall Open, Classified

    Phothera 200, Phototherapy Devices indicated for use to treat diagnosed skin disorders such as, but not limited to, Psoriasis, Vitiligo, and Atopic Dermatitis (Eczema) under the direction of a physician, Model Numbers 210NDT4 and 210NCL4

    Recall: Z-2295-2026 · Initiated December 10, 2025

    Recall

    Recall Number
    Z-2295-2026
    Event Number
    98817
    Firm
    Daavlin Distributing Company
    FEI Number
    1526255
    Product Code
    FTC
    Status
    Open, Classified
    Root Cause
    Labeling Change Control
    Initiated
    December 10, 2025
    Posted
    June 2, 2026
    Address
    205 W Bement St, Bryan, OH, 43506-1264

    Description

    Phothera 200, Phototherapy Devices indicated for use to treat diagnosed skin disorders such as, but not limited to, Psoriasis, Vitiligo, and Atopic Dermatitis (Eczema) under the direction of a physician, Model Numbers 210NDT4 and 210NCL4

    Reason

    Some of the Calibration/Output Certificates had the outputs reversed.

    Action

    An URGENT: MEDICAL DEVICE ADVISORY NOTICE dated 12/11/25 was sent to customers. Dual calibration allows you to treat at the surface (0 ) of the device or at 9 inches (9 ) away. It has come to our attention that some of the Calibration/Output Certificates had the outputs reversed. Actions to be taken by the Customer/User: Talk to your physician regarding treatment plans with the new information listed below. If you have any questions or concerns, please do not hesitate to contact our office at (800) 322-8546. Monday through Friday, 8:00 AM to 4:30 PM, Eastern Time. Thank you for your cooperation.

    Distribution

    US Nationwide distribution.

    Quantity

    368 units