QUANTUM SURGICAL SAS: Device Recall

Recall #Z-1927-2025 · 05/23/2025

Class II: Risk

Recall Details

Recall Number: Z-1927-2025
Classification: Class II
Product Type: Device
Recalling Firm: QUANTUM SURGICAL SAS
Status: Ongoing
Date Initiated: 05/23/2025
Location: montpellier, France
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 4 units in U.S.

Reason for Recall

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

Product Description

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.

Distribution Pattern

Worldwide distribution - U.S. Nationwide distribution in the states of FL,IL, IN, and TX. The countries of France, Germany and United Kingdom.

Other Recalls by QUANTUM SURGICAL SAS

Class II: Risk 08/05/2024

Quantum Surgical has become aware that a component (central axis) inside the Needle Guide product (product number 02-0027) is the subject of rust.

View all recalls by QUANTUM SURGICAL SAS →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.