Class 2 Device Recall EPIONE

• Date Initiated by Firm: May 23, 2025
• Date Posted: June 09, 2025
• Recall Status: Open, Classified
• Recall Number: Z-1927-2025
• Recall Event ID: 96967
• 510(K)Number: K223758
• Product Classification: System, x-ray, tomography, computed - Product Code JAK
• 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.
• Code Information: Model Number: 30-0001 UDI-DI code: 03760305400031 Software Version: 1.0.6.1 Serial Numbers (U.S.): 0322002, 0323006, 0323003 and 0324001
• Recalling Firm/ Manufacturer: QUANTUM SURGICAL SAS; 1000 rue du mas de verchant; ZAC Eureka; montpellier France
• Manufacturer Reason for Recall: Due to a software bug the robotic arm may incorrectly guide the instrument compared to the planning defined by user.
• FDA Determined Cause: Under Investigation by firm
• Action: On or about 05/23/2025, the firm sent via emailed an "URGENT: MEDICAL DEVICE RECALL" Letter to customers informing them that due to a software issue the EPIONE device can place the instrument guide at an incorrect position, compared to the planning defined by the user. Customers are instructed to: 1. Pending the implementation of a corrective action, Quantum Surgical asks all EPIONE device users to NOT plan trajectories along a strictly horizontal direction. To determine if a trajectory is strictly horizontal the following methods can be used: . Patient images acquired in prone or supine orientation: o If the entry and target point are on the same native (non-oblique) axial plane and are on the same native (non-oblique) coronal plane -> the trajectory is strictly horizontal. o If the trajectory is perpendicular to the sagittal plane -> the trajectory is strictly horizontal. . Patient images acquired in lateral decubitus orientation: o If the entry and target point are on the same native (non-oblique) axial plane and are on the same native (non-oblique) sagittal plane -> the trajectory is strictly horizontal. o If the trajectory is perpendicular to the coronal plane -> the trajectory is strictly horizontal. Note - Quantum Surgical reminds that the instrument insertion shall be initiated only after the "Robot on Target" message is displayed, as mentioned in Epione User Manual on page 100. For question or assistance, contact Quantum Surgical on +33 (0) 4 48 19 40 50 between 9am and 6pm, Monday to Friday.
• Quantity in Commerce: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = JAK