QUANTUM SURGICAL SAS
QUANTUM SURGICAL SAS appears in FDA public data with 2 recalls, 2 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1927-2025, Class II) was initiated on May 23, 2025. Its most recent 510(k) clearance was granted on May 3, 2023.
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 2
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-1927-2025 | Class II | EPIONE Model 30-0001 UDI-DI code: 03760305400031 The EPIONE¿ device is a user controlled, stereo | May 23, 2025 |
| Z-0037-2025 | Class II | The EPIONE device v1.0.2 is a user controlled, stereotactic accessory device intended to assist in t | August 5, 2024 |