DermaSensor. Model/Catalog Number: 10101. Software Version: 3.0.2. Software-aided adjunctive d...
FDA Recall #Z-0583-2026 — Class II — October 13, 2025
Product 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 for Recall
Potential for device to not meet specifications resulting in incorrect results or delay of referral for patients.
Recalling Firm
DERMASENSOR INC — Miami, FL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
343 (9 units affected)
Distribution
US distribution to MD, FL, AZ, MS, PA, NY, CT, CA.
Code Information
Lot Code: Model No 10101; UDI-DI 085001778610101A9; Serial Number 1010120241230196E4E, 1010120241240151FD5, 101012024130014EF69, 101012024125014F595, 10101202413001F7C66, 1010120242400172717, 101012024325014CE26, 10101202433101D295C, 101012025093012EE03.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated