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
| Source | FDA Device Enforcement |
|---|---|
| Category | Medical Device |
| Severity | Medium |
| Status | ongoing |
| Recall date | October 13, 2025 |
| Reported | December 03, 2025 |
| Recalling firm | DERMASENSOR INC |
| Country / region | United States FL |
Hazard
Potential for device to not meet specifications resulting in incorrect results or delay of referral for patients.
Affected products
- DermaSensor. Model/Catalog Number: 10101. Software Version: 3.0.2. Software-aided adjunctive diagnostic device for use by physicians on lesions suspicious fo
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