Z-0583-2026 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- December 3, 2025
- Initiation Date
- October 13, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 343 (9 units affected)
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.
Distribution Pattern
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.