Recall Z-1927-2025— QUANTUM SURGICAL SAS
Class II · Ongoing
Class II FDA medical device recall by QUANTUM SURGICAL SAS, initiated 2025-05-23. It names one FDA 510(k) clearance: K223758. 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.. Reason: Due to a software bug the robotic arm may incorrectly guide the instrument compared to the planning defined by user..
- Recalling firm
- QUANTUM SURGICAL SAS
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-05-23
- Firm location
- montpellier, France
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
Due to a software bug the robotic arm may incorrectly guide the instrument compared to the planning defined by user.
Data sourced from openFDA. This site is unofficial and independent of the FDA.