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
- Company
- Dermasensor Inc
- Recall Initiated
- October 13, 2025
- Posted
- November 21, 2025
- Recall Number
- Z-0583-2026
- Quantity
- 343 (9 units affected)
- Firm Location
- Miami, FL
Reason for Recall
Potential for device to not meet specifications resulting in incorrect results or delay of referral for patients.
Distribution
US distribution to MD, FL, AZ, MS, PA, NY, CT, CA.
Lot / Code Info
Lot Code: Model No 10101; UDI-DI 085001778610101A9; Serial Number 1010120241230196E4E, 1010120241240151FD5, 101012024130014EF69, 101012024125014F595, 10101202413001F7C66, 1010120242400172717, 101012024325014CE26, 10101202433101D295C, 101012025093012EE03.
Root Cause
Process control
Action Taken
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.