FDAHealthOctober 13, 2025
DERMASENSOR INC — 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.
Is this relevant to me?
- Geography
- US, MD, FL, AZ, MS, PA, NY, CT, CA
- Source agency
- FDA
- Category
- Health
- Published
- October 13, 2025
US distribution to MD, FL, AZ, MS, PA, NY, CT, CA.
What's affected?
- Product
- 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
- Brand
- DERMASENSOR INC
- Lot code
- Model
Additional details
Lot Code: Model No 10101; UDI-DI 085001778610101A9; Serial Number 1010120241230196E4E, 1010120241240151FD5, 101012024130014EF69, 101012024125014F595, 10101202413001F7C66, 1010120242400172717, 101012024325014CE26, 10101202433101D295C, 101012025093012EE03.
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 343 (9 units affected).
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