BEUDAMED
    FDA Recall Open, Classified

    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 · Initiated October 13, 2025

    Recall

    Recall Number
    Z-0583-2026
    Event Number
    97780
    Firm
    DERMASENSOR INC
    FEI Number
    3017254114
    Product Code
    QZS
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    October 13, 2025
    Posted
    November 21, 2025
    Address
    801 Brickell Ave, Ste 1610, Miami, FL, 33131-4901

    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.

    Action

    DermaSensor began notification of consignees on about 10/13/2025 via telephone call with a follow up letter. The telephone call notified consignees of the issue and confirmed if the affected units were or were not on hand. The letter then sent to the consignees again advised them of the issue and instructed them to examine inventory for affected units, to complete and return the Customer Notification Response Form, and arrange a visit with DermaSensor for the device correction. Once the affected unit is examined, DermaSensor can determine if the device contains the component issue and if it does, DermaSensor will provide the consignee with the dates the scans were taken and the correct results. If the consignee's device does not contain the component issue, no further actions need to be taken.

    Distribution

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

    Quantity

    343 (9 units affected)