FDAOctober 13, 2025device

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Ongoing

Brands named

dermasensor

Recall history

No related federal recalls on record for this brand yet.

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