DermaSensor. Model/Catalog Number: 10101. Software Version: 3.0.2. Software-aided adjunctive diagnostic device for us
Summary
The FDA issued a Class II for DermaSensor. Model/Catalog Number: 10101. Software Version: 3.0.2. Software-a by DERMASENSOR INC. Reason: Potential for device to not meet specifications resulting in incorrect results or delay of referral for patients..
Details
Source
Device Recall
External ID
Z-0583-2026
Action Date
2025-12-03
Status
Ongoing
Category
device
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
Lot/Code Info: Lot Code: Model No 10101; UDI-DI 085001778610101A9; Serial Number 1010120241230196E4E, 1010120241240151FD5, 101012024130014EF69, 101012024125014F595, 10101202413001F7C66, 1010120242400172717, 101012024325014CE26, 10101202433101D295C, 101012025093012EE03.
Quantity Affected: 343 (9 units affected)
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-10-13
Company
Miami, FL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 254 device recalls issued in the same week, part of 403 device-related FDA actions this month.
DERMASENSOR INC has 2 FDA actions in our database, including 1 recall and 1 clearance.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (DERMASENSOR INC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does DERMASENSOR INC have FDA actions?
DERMASENSOR INC has 2 FDA actions in our database, including 1 recall and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0583-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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