Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Reflexion Medical with 4 device recalls and 2 510(k) clearances. The most recent is a device recall dated Feb 9, 2026: RefleXion X1 Radiotherapy System Model RXM1000, Part #800-00006-00.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Feb 9, 2026 | RefleXion X1 Radiotherapy System Model RXM1000, Part #800-00006-00Class II · Due to a radiotherapy medical system software defect, when performing angular roll corrections followed by a repeat loca | Device recalls |
| Dec 18, 2025 | RefleXion Medical Radiotherapy System, Reflexion X2K252071 · QVA | 510(k) clearances |
| Jul 22, 2025 | RefleXion X1 Model RXM1000 UDI Codes: (01)00860003983812(11)230504(21)X11001 (01)00860003983812(11)230518(21)X11002 (01)00860003983812(1Class II · Due to incorrect software configuration that potentially allows more than two (2) fractions within a 12-hour period (fra | Device recalls |
| Apr 16, 2024 | RefleXion X1 Radiotherapy System Model RXM1000 Software version 2.1.19-3 Radiation therapy system is a device that combines the functionaliClass II · A potential dose error exists for patients treated with an out of session SCINTIX partial fraction. | Device recalls |
| Feb 1, 2023 | RefleXion Medical Radiotherapy System (RMRS)DEN220014 · QVA | 510(k) clearances |
| Nov 24, 2021 | RefleXion Medical Radiotherapy System - System Label: "*** refleXion REF RXM1000 ***" Physics Guide/Treatment Delivery User Manual/TrClass II · Due to dose discrepancy when delivering a plan to a patient in a Non-HFS (Head First Supine) orientation specifically in | Device recalls |
| Mar 12, 2020 | RefleXion Medical Radiotherapy SystemK190978 · IYE | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
