Device recall
Z-0037-2025: The EPIONE device v1.0.2 is a user controlled, stereotactic accessory device…
FDA device recall · Class II · QUANTUM SURGICAL SAS
Key facts
| Recall number (Z-number) | Z-0037-2025 |
|---|---|
| Recall event | 95194 |
| Product | The EPIONE device v1.0.2 is a user controlled, stereotactic accessory device intended to assist in the planning and manual advancement of one or more instruments, as well as in verification of instrument position during Computed Tomography (CT) guided percutaneous procedures. During the planning… |
| Product code | JAK |
| Recalling firm | QUANTUM SURGICAL SAS |
| Recall class | Class II |
| Status | Completed |
| 510(k) numbers | K223758 |
| FEI number | 3023140882 |
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