EPIONE Model 30-0001 (Unknown) – Software Guidance Error (2025)
This recall may present a risk under certain conditions.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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 r
Lot Codes / Batch Numbers
0323006, 0323003 and 0324001
Products Sold
Model Number: 30-0001 UDI-DI code: 03760305400031 Software Version: 1.0.6.1 Serial Numbers (U.S.): 0322002, 0323006, 0323003 and 0324001
A medical device manufacturer is recalling EPIONE Model 30-0001 UDI-DI code: 03760305400031 The EPIONE device is a user controlled, stereotact due to Due to a software bug the robotic arm may incorrectly guide the instrument compared to the planning defined by user.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Due to a software bug the robotic arm may incorrectly guide the instrument compared to the planning defined by user.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026