FDAFDA · Food and drugs·Recall number 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.
Published October 16, 2024 · Recall initiated: August 5, 2024
Status when published: Completed — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Quantum Surgical has become aware that a component (central axis) inside the Needle Guide product (product number 02-0027) is the subject of rust.
What to do
Voluntary: Firm initiated · Visit
Recall details
- Manufacturer
- QUANTUM SURGICAL SAS
- Distributor
- US Nationwide distribution in the state of FL.
- Lot
- UDI/DI 37603054002NGXL, serial numbers: 0321015 and 0321017
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- France
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.