FDA Device recall Z-0037-2025
The EPIONE device v1.0.2 is a user controlled, stereotactic accessory device intended to assist in the planning and manual advancement of o…
- FDA Device
- Class II
- completed
- Published 2024-10-16
On 2024-10-16 the FDA classified a Class II recall of The EPIONE device v1.0.2 is a user controlled, stereotactic accessory device intended to assist in the planning and manual advancement of o… by Quantum Surgical Sas, citing quantum Surgical has become aware that a component (central axis) inside the Needle Guide product (product number 02-0027) is the subject of rust.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0037-2025 |
| Classification | Class II |
| Status | completed |
| Initiated | 2024-08-05 |
| Published | 2024-10-16 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Quantum Surgical Sas |
| Distribution | US |
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.
Reason
Quantum Surgical has become aware that a component (central axis) inside the Needle Guide product (product number 02-0027) is the subject of rust.
Identifiers
| code_info | UDI/DI 37603054002NGXL, serial numbers: 0321015 and 0321017 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: completed.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0037-2025%22
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