The EPIONE device v1 — Class II medical device recall Z-0037-2025
Completed recall by QUANTUM SURGICAL SAS, reported 2024-10-16, distributed nationwide. Quantum Surgical has become aware that a component (central axis) inside the Needle Guide product (product num
| Recall number | Z-0037-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | QUANTUM SURGICAL SAS, montpellier, France |
| Recall initiated | 2024-08-05 |
| Classified | 2024-10-09 |
| Reported by FDA | 2024-10-16 |
| Distributed | Nationwide (US) |
| Quantity | 2 units |
| Serial numbers | 0321015, 0321017 |
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 phase, the desired instrument placement and performance is defined relative to the target anatomy. During the guidance phase, the device enables to monitor respiratory levels and verify patient position prior to instrument advancement. During the assessment phase, the achieved instrument placement and performance are displayed relative to the previously defined plan through an overlay of the pre- and post-treatment image data.
Reason for recall
Quantum Surgical has become aware that a component (central axis) inside the Needle Guide product (product number 02-0027) is the subject of rust.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0037-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.