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
Reported: December 3, 2025 Initiated: October 13, 2025 #Z-0583-2026
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
Reason for Recall
Potential for device to not meet specifications resulting in incorrect results or delay of referral for patients.
Details
- Recalling Firm
- DERMASENSOR INC
- Units Affected
- 343 (9 units affected)
- Distribution
- US distribution to MD, FL, AZ, MS, PA, NY, CT, CA.
- Location
- Miami, FL
Frequently Asked Questions
What product 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. Recalled by DERMASENSOR INC. Units affected: 343 (9 units affected).
Why was this product recalled? ▼
Potential for device to not meet specifications resulting in incorrect results or delay of referral for patients.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 3, 2025. Severity: Moderate. Recall number: Z-0583-2026.
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