The EPIONE device v1.0.2 is a user controlled, stereotactic accessory device intended to assist in the planning and manu
FDA device recall Z-0037-2025 · posted 2024-10-09 · Completed
Recall details
- Recalling firm
- QUANTUM SURGICAL SAS
- 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.
- Action taken
- Quantum Surgical issued an URGENT FIELD SAFETY NOTICE to its sole consignee via visit on 08/05/2024 and followed up with an email on 08/19/2024. The notice explained the problem, potential risk, and requested that the consignee cease use of the device. The affected units were returned, repaired, and replaced.
- Root cause
- Under Investigation by firm
- Status
- Completed
- Product code
- JAK
- Quantity affected
- 2 units
- Distribution
- US Nationwide distribution in the state of FL.
- Date initiated
- 2024-08-05
- Date posted
- 2024-10-09
- Location
- montpellier, France
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Epione (K223758) | Quantum Surgical Sas | 2023-05-03 |