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
Potential for device to not meet specifications resulting in incorrect results or delay of referral for patients.
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Recall Number
Z-0583-2026
Classification
Class II
Status
Ongoing
Category
device
Initiated
2025-10-13
Reported
2025-12-03
Distribution
US distribution to MD, FL, AZ, MS, PA, NY, CT, CA.
Code Info
Lot Code: Model No 10101; UDI-DI 085001778610101A9; Serial Number 1010120241230196E4E, 1010120241240151FD5, 101012024130014EF69, 101012024125014F595, 10101202413001F7C66, 1010120242400172717, 101012024325014CE26, 10101202433101D295C, 101012025093012EE03.
Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.