Recall Z-0037-2025 ยท JAK System, X-Ray, Tomography, Computed
QUANTUM SURGICAL SAS
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 phase, the desired instrument placement and performance is defined relative to the target anatomy. Duri
| Date | Oct 9, 2024 (initiated Aug 5, 2024) |
| Status | Completed |
| Reason | Quantum Surgical has become aware that a component (central axis) inside the Needle Guide product (product number 02-0027) is the subject of rust. |
| Root cause | Under Investigation by firm |
| Action | Quantum Surgical issued an URGENT FIELD SAFETY NOTICE to its sole consignee via visit on 08/05/2024 and followed up with an email on 08/19/2024. The notice explained the problem, potential risk, and requested that the consignee cease use of the device. The affected units were returned, repaired, and replaced. |
| Quantity | 2 units |
| Distribution | US Nationwide distribution in the state of FL. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K223758 | Epione Quantum Surgical Sas, May 3, 2023 |