FDAFDA · Alimentos y medicamentos·N.º oficial 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.
Publicado el 18 de junio de 2025 · Inicio del retiro: 23 de mayo de 2025
Estado reportado al momento de publicación: Ongoing — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
Due to a software bug the robotic arm may incorrectly guide the instrument compared to the planning defined by user.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- QUANTUM SURGICAL SAS
- Distribuidor
- Worldwide distribution - U.S. Nationwide distribution in the states of FL,IL, IN, and TX. The countries of France, Germany and United Kingdom.
- Lote
- Model Number: 30-0001 UDI-DI code: 03760305400031 Software Version: 1.0.6.1 Serial Numbers (U.S.): 0322002, 0323006, 0323003 and 0324001
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- France
¿Vendes productos como este?
Recalert vigila todo tu catálogo contra retiros como este, automáticamente.