DERMASENSOR INC recalls DermaSensor. Model/Catalog Number: 10101. Software Version: 3.0.2. Software-aided adjunctive diagnostic device for use…

Recall date

October 13, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0583-2026

FDA classification

Class II

Brand / firm

DERMASENSOR INC

Sold / distributed

US distribution to MD, FL, AZ, MS, PA, NY, CT, CA.

Why it was recalled

Potential for device to not meet specifications resulting in incorrect results or delay of referral for patients.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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