EPIONE Model 30-0001 UDI-DI code: 03760305400031 The EPIONE device is a user controlled, stereotactic accessory intended
FDA device recall Z-1927-2025 · posted 2025-06-09 · Open, Classified
Recall details
- Recalling firm
- QUANTUM SURGICAL SAS
- Reason for recall
- Due to a software bug the robotic arm may incorrectly guide the instrument compared to the planning defined by user.
- Action taken
- 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.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- JAK
- Quantity affected
- 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.
- Date initiated
- 2025-05-23
- Date posted
- 2025-06-09
- Location
- montpellier, France
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Epione (K223758) | Quantum Surgical Sas | 2023-05-03 |