Recall Z-1927-2025 ยท JAK System, X-Ray, Tomography, Computed
QUANTUM SURGICAL SAS
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
| Date | Jun 9, 2025 (initiated May 23, 2025) |
| Status | Open, Classified |
| Reason | Due to a software bug the robotic arm may incorrectly guide the instrument compared to the planning defined by user. |
| Root 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 orie |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K223758 | Epione Quantum Surgical Sas, May 3, 2023 |