FDA recall Z-0583-2026

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

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.

Key facts

Status

Ongoing

Initiation date

2025-10-13

Report date

2025-12-03

Voluntary/Mandated

Voluntary: Firm initiated

Location

Miami, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0583-2026