Z-1927-2025Class II

EPIONE Model 30-0001 UDI-DI code: 03760305400031 The EPIONE device is a user controlled, stereotactic...

Name: Z-1927-2025 EPIONE Model 30-0001 UDI-DI code: 03760305400031 The EPIONE device is a user controlled, stereotactic...
Creator: Quantum Surgical Sas
Published: 2025-05-23
License: https://open.fda.gov/license/

Quantum Surgical SAS / initiated 2025-05-23 / Open, Classified / root cause: software

FDA source

QUANTUM SURGICAL SAS began a recall of 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... on 2025-05-23. FDA classified it as Class II and gives the reason as "Due to a software bug the robotic arm may incorrectly guide the instrument compared to the planning defined by user". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-1927-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-05-23
Posted: 2025-06-09
Recalling firm: Quantum Surgical SAS
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.
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: Due to a software bug the robotic arm may incorrectly guide the instrument compared to the planning defined by user.
Root cause tag: software
FDA 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 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.
Product codes and lots: Model Number: 30-0001 UDI-DI code: 03760305400031 Software Version: 1.0.6.1 Serial Numbers (U.S.): 0322002, 0323006, 0323003 and 0324001

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1927-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1927-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-06-18	2025-06-09

Product code JAK

K223758Class IIEpioneQuantum Surgical Sas / cleared 2023-05-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)