Reflexion Medical, Inc.
Reflexion Medical, Inc. appears in FDA public data with 4 recalls, 3 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent recall (Z-1656-2026, Class II) was initiated on February 9, 2026. Its most recent 510(k) clearance was granted on December 18, 2025.
Summary
- Total Recalls
- 4
- 510(k) Clearances
- 3
- Inspections
- 1
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-1656-2026 | Class II | RefleXion X1 Radiotherapy System Model RXM1000, Part #800-00006-00 | February 9, 2026 |
| Z-2486-2025 | Class II | RefleXion X1 Model RXM1000 UDI Codes: (01)00860003983812(11)230504(21)X11001 (01)00860003983812(1 | July 22, 2025 |
| Z-1933-2024 | Class II | RefleXion X1 Radiotherapy System Model RXM1000 Software version 2.1.19-3 Radiation therapy system i | April 16, 2024 |
| Z-0470-2022 | Class II | RefleXion Medical Radiotherapy System - System Label: "*** refleXion REF RXM1000 ***" Physics | November 24, 2021 |