Company: QUANTUM SURGICAL SAS
Date of Enforcement Report: 6/9/2025
Class: II

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 anesthesia with rigid straight instruments such as needles and probes of diameters ranging from 11G to 19G

Recall Number:

Z-1927-2025

REASON:

Due to a software bug the robotic arm may incorrectly guide the instrument compared to the planning defined by user.

RECALLING FIRM/MANUFACTURER:

QUANTUM SURGICAL SAS

VOLUME:

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