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U.S. Department of Health and Human Services

Class 2 Device Recall DermaSensor

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 Class 2 Device Recall DermaSensorsee related information
Date Initiated by FirmOctober 13, 2025
Date PostedNovember 21, 2025
Recall Status1 Open3, Classified
Recall NumberZ-0583-2026
Recall Event ID 97780
Product Classification Software-aided adjunctive diagnostic device for use by physicians on lesions suspicious for skin cancer - Product Code QZS
ProductDermaSensor. Model/Catalog Number: 10101. Software Version: 3.0.2. Software-aided adjunctive diagnostic device for use by physicians on lesions suspicious for skin cancer
Code Information Lot Code: Model No 10101; UDI-DI 085001778610101A9; Serial Number 1010120241230196E4E, 1010120241240151FD5, 101012024130014EF69, 101012024125014F595, 10101202413001F7C66, 1010120242400172717, 101012024325014CE26, 10101202433101D295C, 101012025093012EE03.
Recalling Firm/
Manufacturer		 DERMASENSOR INC
801 Brickell Ave Ste 1610
Miami FL 33131-4901
For Additional Information ContactRyan Frieden
01-855-3736767 Ext. 605
Manufacturer Reason
for Recall		Potential for device to not meet specifications resulting in incorrect results or delay of referral for patients.
FDA Determined
Cause 2		Process control
ActionDermaSensor 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.
Quantity in Commerce343 (9 units affected)
DistributionUS distribution to MD, FL, AZ, MS, PA, NY, CT, CA.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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