Device recall
Z-0678-2025: Hybrid Recon software on Hermes Medical Imaging Suite version 6.1 Hybrid Recon…
FDA device recall · Class II · Hermes Medical Solutions AB
Key facts
| Recall number (Z-number) | Z-0678-2025 |
|---|---|
| Recall event | 95673 |
| Product | Hybrid Recon software on Hermes Medical Imaging Suite version 6.1 Hybrid Recon software versions affected are 4.0.0x and 5.0.0 |
| Product code | KPS |
| Recalling firm | Hermes Medical Solutions AB |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K171681 |
| FEI number | 3002831423 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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