Reflexion Medical, Inc. recalls
Every recall we track for Reflexion Medical, Inc. — 4 in all, from 2021–2026 — plus the complaints and injury reports the public filed about them.
Recalls per year, by danger level
4 recalls since 2017.
All FDA recall records for Reflexion Medical, Inc. since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 1 | 0 | 0 | 1 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 0 | 1 | 1 |
| 2025 | 0 | 1 | 0 | 0 | 1 |
| 2026 (to date) | 0 | 1 | 0 | 0 | 1 |
What to do if you have a recalled Reflexion Medical, Inc. product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All Reflexion Medical, Inc. recalls
4 shown- Use cautionMedical device
Reflexion Medical, Inc. recalls RefleXion X1 Radiotherapy System Model RXM1000, Part #800-00006-00
Reflexion Medical recalls X1 Radiotherapy System Model RXM1000 with software versions 2.1.29-4 and 2.1.35-1 due to potential dose misdelivery. Affected units may receive 5mm+ displacement or 10-20% underdose.
Reflexion MedicalFeb 9, 2026 - Use cautionMedical device
Reflexion Medical, Inc. recalls RefleXion X1 Model RXM1000 UDI Codes: (01)00860003983812(11)230504(21)X11001 (01)00860003983812(11)230518(21)X11002
Reflexion Medical recalls specific models of X1 radiation therapy systems due to software configuration that could allow more than two fractions in 12 hours, potentially causing toxicity. Affected units have unique UDI codes listed.
Reflexion MedicalJul 22, 2025 - UnratedMedical device
Reflexion Medical, Inc. recalls RefleXion X1 Radiotherapy System Model RXM1000 Software version 2.1.19-3 Radiation therapy system is a device that
Reflexion Medical recalls X1 Radiotherapy System software version 2.1.19-3 due to potential dose errors for patients treated with out-of-session SCINTIX partial fractions. Affected units have specific UDI codes.
Reflexion MedicalApr 16, 2024 - Use cautionMedical device
Reflexion Medical, Inc. recalls RefleXion Medical Radiotherapy System - System Label: "*** refleXion REF RXM1000 ***" Physics Guide/Treatment Delivery
Reflexion Medical recalls RXM1000 radiotherapy systems due to dose discrepancies when treating patients in Feet First Supine (FFS) positions. Affected units have specific serial numbers and model labels.
Reflexion MedicalNov 24, 2021
Reflexion Medical, Inc. recall questions
How many recalls has Reflexion Medical, Inc. had?
4 recalls from Reflexion Medical, Inc. are on record with U.S. safety agencies, from 2021–2026.
What is the most recent Reflexion Medical, Inc. recall?
Reflexion Medical, Inc. recalls RefleXion X1 Radiotherapy System Model RXM1000, Part #800-00006-00, dated Feb 9, 2026. Every Reflexion Medical, Inc. recall is listed on this page, newest first.
What should I do if I have a recalled Reflexion Medical, Inc. product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new Reflexion Medical, Inc. recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.