Montpellier, FR · 2 510(k) clearances · 2 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| JAK | System, X-Ray, Tomography, Computed | Class II | Radiology | 2 | 2023-05-03 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2025-05-23 | Class II | Ongoing | Z-1927-2025 | EPIONE Model 30-0001 UDI-DI code: 03760305400031 The EPIONE¿ device is a user controlled, stereotactic accessory int… | — | Due to a software bug the robotic arm may incorrectly guide the instrument compared to the planning defined by user. |
| 2024-08-05 | Class II | Completed | Z-0037-2025 | The EPIONE device v1.0.2 is a user controlled, stereotactic accessory device intended to assist in the planning and manu… | — | Quantum Surgical has become aware that a component (central axis) inside the Needle Guide product (product number 02-0027) is the subject of rust. |