Device recall
Z-0583-2026: DermaSensor. Model/Catalog Number: 10101. Software Version: 3.0.2…
FDA device recall · Class II · DERMASENSOR INC
Key facts
| Recall number (Z-number) | Z-0583-2026 |
|---|---|
| Recall event | 97780 |
| 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 |
| Product code | QZS |
| Recalling firm | DERMASENSOR INC |
| Recall class | Class II |
| Status | Open, Classified |
| FEI number | 3017254114 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database