Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
EPIONE Model 30-0001 UDI-DI code: 03760305400031 The EPIONE¿ device is Recalled by QUANTUM SURGICAL SAS Due to Due to a software bug the robotic arm...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact QUANTUM SURGICAL SAS directly.
Affected Products
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.
Why Was This Recalled?
Due to a software bug the robotic arm may incorrectly guide the instrument compared to the planning defined by user.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About QUANTUM SURGICAL SAS
QUANTUM SURGICAL SAS has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report