QUANTUM SURGICAL SAS: Medical Device Recall in 2025 - (Recall #: Z-1927-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: May 23, 2025

Date Posted: June 18, 2025

Recall Number: Z-1927-2025

Event ID: 96967

Reason for Recall:

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

Status: Ongoing

Product Quantity: 4 units in U.S.

Code Information:

Model Number: 30-0001 UDI-DI code: 03760305400031 Software Version: 1.0.6.1 Serial Numbers (U.S.): 0322002, 0323006, 0323003 and 0324001

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.

Voluntary or Mandated:

Voluntary: Firm initiated