PlainRecalls
FDA Devices Moderate Class II Ongoing

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 diamet

Reported: June 18, 2025 Initiated: May 23, 2025 #Z-1927-2025

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.

Reason for Recall

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

Details

Recalling Firm
QUANTUM SURGICAL SAS
Units 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.
Location
montpellier

Frequently Asked Questions

What product was recalled?
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.. Recalled by QUANTUM SURGICAL SAS. Units affected: 4 units in U.S..
Why was this product recalled?
Due to a software bug the robotic arm may incorrectly guide the instrument compared to the planning defined by user.
Which agency issued this recall?
This recall was issued by the FDA Devices on June 18, 2025. Severity: Moderate. Recall number: Z-1927-2025.