Device 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.
Z-1927-2025
Product summary
- Event
- Event 96967
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 4 units in U.S.
- Official record key
device-enforcement:Z-1927-2025
Official wording
Reason: Due to a software bug the robotic arm may incorrectly guide the instrument compared to the planning defined by user.
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.
Derived failure modes
-
Device software or design
software bug