Class II — QUANTUM SURGICAL SAS
| Recalling firm | Quantum Surgical SAS |
|---|---|
| Registered facility | QUANTUM SURGICAL SAS (the firm's only registered facility) |
| Classification | Class II |
| 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. |
| 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… |
| Quantity | 2 units |
| Distribution | US Nationwide distribution in the state of FL. |
| Initiated | 2024-08-05 |
| Classified | 2024-10-09 |
| Recall number | Z-0037-2025 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — QUANTUM SURGICAL SAS (Z-0037-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/95194/
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