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 | Ongoing |
| Reason | Due to a software bug the robotic arm may incorrectly guide the instrument compared to the planning defined by user. |
| 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 ablation procedures in the abdomen, performed by physicians trained for CT procedures and performed under general anaesthesia with rigid straight instruments such as needles and probes of diameters ranging from 11G to 19G. |
| Quantity | 4 units in U.S. |
| Distribution | Worldwide distribution - U.S. Nationwide distribution in the states of FL,IL, IN, and TX. The countries of France, Germany and United Kingdom. |
| Initiated | 2025-05-23 |
| Classified | 2025-06-09 |
| Recall number | Z-1927-2025 |
| 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-1927-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/96967/
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