QUANTUM SURGICAL SAS recalls The EPIONE device v1.0.2 is a user controlled, stereotactic accessory device intended to assist in the planning and man…

Recall date

August 5, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0037-2025

FDA classification

Class II

Brand / firm

QUANTUM SURGICAL SAS

Sold / distributed

US Nationwide distribution in the state of 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.