Device recall
Z-1927-2025: EPIONE Model 30-0001 UDI-DI code: 03760305400031 The EPIONE device is a user…
FDA device recall · Class II · QUANTUM SURGICAL SAS
Key facts
| Recall number (Z-number) | Z-1927-2025 |
|---|---|
| Recall event | 96967 |
| Product | EPIONE Model 30-0001 UDI-DI code: 03760305400031 The EPIONE device is a user controlled, stereotactic accessory 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… |
| Product code | JAK |
| Recalling firm | QUANTUM SURGICAL SAS |
| Recall class | Class II |
| Status | Open, Classified |
| 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