QUANTUM SURGICAL SAS recalls EPIONE Model 30-0001 UDI-DI code: 03760305400031 The EPIONE¿ device is a user contr…

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

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.

• FDA enforcement recordOfficial FDA database entry for Z-1927-2025
• FDA 510(k) clearance · K223758The device's official FDA premarket clearance record
• FDA device classification · JAKOfficial FDA classification for this device type
• CFR regulation · 21 CFR 892.1750The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find QUANTUM SURGICAL SASSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.