Reported Oct 16, 2024 · Completed
The EPIONE device v1.0.2 is a user controlled, stereotactic accessory device intended to assist in the planning and…
Quantum Surgical Sas
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: QUANTUM SURGICAL SAS · 1000 rue du mas de verchant · montpellier · N/A
Is this the product you have?
- 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.
- Lot codes and dates
- UDI/DI 37603054002NGXL
- serial numbers0321015 and 0321017
- Amount recalled
- 2 units
Where it was sold
- Nationwide
- FL
Why it was recalled
Quantum Surgical has become aware that a component (central axis) inside the Needle Guide product (product number 02-0027) is the subject of rust.
This product could cause temporary or reversible health problems — stop using it.
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