Z-1927-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- June 18, 2025
- Initiation Date
- May 23, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4 units in U.S.
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.
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.
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