Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
The EPIONE device v1.0.2 is a user controlled Recalled by QUANTUM SURGICAL SAS Due to Quantum Surgical has become aware that a component...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact QUANTUM SURGICAL SAS directly.
Affected Products
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.
Quantity: 2 units
Why Was This 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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About QUANTUM SURGICAL SAS
QUANTUM SURGICAL SAS has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report