QUANTUM SURGICAL SAS: Device Recall

Recall #Z-0037-2025 · 08/05/2024

Class II: Risk

Recall Details

Recall Number
Z-0037-2025
Classification
Class II
Product Type
Device
Recalling Firm
QUANTUM SURGICAL SAS
Status
Completed
Date Initiated
08/05/2024
Location
montpellier, France
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2 units

Reason for Recall

Quantum Surgical has become aware that a component (central axis) inside the Needle Guide product (product number 02-0027) is the subject of rust.

Product Description

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.

Distribution Pattern

US Nationwide distribution in the state of FL.

Other Recalls by QUANTUM SURGICAL SAS

View all recalls by QUANTUM SURGICAL SAS →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.