FDAFDA · Food and drugs·Recall number Z-1927-2025
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.
Published June 18, 2025 · Recall initiated: May 23, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Due to a software bug the robotic arm may incorrectly guide the instrument compared to the planning defined by user.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- QUANTUM SURGICAL SAS
- Distributor
- Worldwide distribution - U.S. Nationwide distribution in the states of FL,IL, IN, and TX. The countries of France, Germany and United Kingdom.
- Lot
- Model Number: 30-0001 UDI-DI code: 03760305400031 Software Version: 1.0.6.1 Serial Numbers (U.S.): 0322002, 0323006, 0323003 and 0324001
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- France
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