Reported Jun 18, 2025 · Ongoing
EPIONE Model 30-0001 UDI-DI code: 03760305400031 The EPIONE¿ device is a user controlled, stereotactic accessory…
Quantum Surgical Sas
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: QUANTUM SURGICAL SAS · 1000 rue du mas de verchant · montpellier · N/A
Is this the product you have?
- EPIONE Model 30-0001 UDI-DI code03760305400031 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
- Lot codes and dates
- Model Number30-0001
- UDI-DI code03760305400031
- Software Version
1.0.6.1 Serial Numbers (U.S.): 032200203230060323003 and 0324001
- Amount recalled
- 4 units in U.S.
Where it was sold
Why it was recalled
Due to a software bug the robotic arm may incorrectly guide the instrument compared to the planning defined by user.
This product could cause temporary or reversible health problems — stop using it.
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