BEUDAMED
    FDA Enforcement Class II Ongoing

    DermaSensor. Model/Catalog Number: 10101. Software Version: 3.0.2. Software-aided adjunctive diagnostic device for use by physicians on lesions suspicious for skin cancer

    Recall: Z-0583-2026 · Reported December 3, 2025

    Enforcement

    Recall Number
    Z-0583-2026
    Event ID
    97780
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    DERMASENSOR INC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    December 3, 2025
    Initiation Date
    October 13, 2025
    Classification Date
    November 21, 2025
    Address
    801 Brickell Ave Ste 1610, N/A, Miami, FL, 33131-4901, United States

    Description

    DermaSensor. Model/Catalog Number: 10101. Software Version: 3.0.2. Software-aided adjunctive diagnostic device for use by physicians on lesions suspicious for skin cancer

    Reason

    Potential for device to not meet specifications resulting in incorrect results or delay of referral for patients.

    Code Info

    Lot Code: Model No 10101; UDI-DI 085001778610101A9; Serial Number 1010120241230196E4E, 1010120241240151FD5, 101012024130014EF69, 101012024125014F595, 10101202413001F7C66, 1010120242400172717, 101012024325014CE26, 10101202433101D295C, 101012025093012EE03.

    Distribution

    US distribution to MD, FL, AZ, MS, PA, NY, CT, CA.

    Quantity

    343 (9 units affected)