DermaSensor (DermaSensor) – Result Specification Risk (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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 Codes / Batch Numbers
Lot Code: Model No 10101, UDI-DI 085001778610101A9, Serial Number 1010120241230196E4E, 1010120241240151FD5, 101012024130014EF69, 101012024125014F595, 10101202413001F7C66, 1010120242400172717, 101012024325014CE26, 10101202433101D295C, 101012025093012EE03.
Products Sold
Lot Code: Model No 10101; UDI-DI 085001778610101A9; Serial Number 1010120241230196E4E, 1010120241240151FD5, 101012024130014EF69, 101012024125014F595, 10101202413001F7C66, 1010120242400172717, 101012024325014CE26, 10101202433101D295C, 101012025093012EE03.
DERMASENSOR INC is recalling DermaSensor. Model/Catalog Number: 10101. Software Version: 3.0.2. Software-aided adjunctive diagno due to Potential for device to not meet specifications resulting in incorrect results or delay of referral for patients.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Potential for device to not meet specifications resulting in incorrect results or delay of referral for patients.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AZ, CA, CT, FL, MD, MS, NY, PA
Page updated: Jan 10, 2026