FDA Medical devices recall ·
The EPIONE device v1.0.2 is a user controlled… recall
- Recall number
- Z-0037-2025
- Date
- (initiated August 5, 2024)
- Company / brand
- Quantum Surgical Sas
1000 rue du mas de verchant, montpellier, France - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Completed
- Units affected
- 2 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
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.
Why was it 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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI/DI 37603054002NGXL, serial numbers: 0321015 and 0321017
Distribution
US Nationwide distribution in the state of FL.
States: Florida
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0037-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.