FDAFDA · Alimentos y medicamentos·N.º oficial Z-0037-2025
The EPIONE device v1.0.2 is a user controlled, stereotactic accessory device 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 procedures. During the planning phase, the desired instrument placement and performance is defined relative to the target anatomy. During the guidance phase, the device enables to monitor respiratory levels and verify patient position prior to instrument advancement. During the assessment phase, the achieved instrument placement and performance are displayed relative to the previously defined plan through an overlay of the pre- and post-treatment image data.
Publicado el 16 de octubre de 2024 · Inicio del retiro: 5 de agosto de 2024
Estado reportado al momento de publicación: Completed — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
Quantum Surgical has become aware that a component (central axis) inside the Needle Guide product (product number 02-0027) is the subject of rust.
Qué hacer
Voluntary: Firm initiated · Visit
Detalles del retiro
- Fabricante
- QUANTUM SURGICAL SAS
- Distribuidor
- US Nationwide distribution in the state of FL.
- Lote
- UDI/DI 37603054002NGXL, serial numbers: 0321015 and 0321017
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- France
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