UnratedMedical device recall · FDA · Published April 16, 2024
Reflexion X1 Radiotherapy System Software Version 2.1.19-3: Potential Dose Error Risk
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.
A potential dose error exists for patients treated with an out of session SCINTIX partial fraction.
Take action
Contact the company
📍Recalling firmReflexion Medical, Inc.25881 Industrial Blvd · Hayward, CA 94545-2991
✎ GovInfoNow plain-language explainer
Reflexion Medical is recalling its X1 Radiotherapy System software version 2.1.19-3 because it may cause incorrect radiation doses for patients receiving treatment with out-of-session SCINTIX partial fractions. This could lead to improper treatment outcomes if not corrected. Read more at govinfonow.com/recall/55389-reflexion-x1-radiotherapy-system-software-version-2-1-19-3.
“Reflexion X1 Radiotherapy System Software Version 2.1.19-3: Potential Dose Error Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/55389-reflexion-x1-radiotherapy-system-software-version-2-1-19-3. Based on FDA recall #Z-1933-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1933-2024%22&limit=1).
The FDA announced on April 16, 2024, that Reflexion Medical, Inc. voluntarily recalled its RefleXion X1 Radiotherapy System Model RXM1000 Software version 2.1.19-3 due to a potential dose error for patients treated with an out-of-session SCINTIX partial fraction.
How to tell if you have it
RefleXion X1 Radiotherapy System Model RXM1000
Software version 2.1.19-3
UPC 00860003983812
System serial numbers: (01)00860003983812(11)230504(21)X11001, (01)00860003983812(11)230518(21)X11002, (01)00860003983812(11)230505(21)X11003, (01)00860003983812(11)230530(21)X11004, (01)00860003983812(11)230811(21)X11006, (01)00860003983812(11)230410(21)X11007, (01)00860003983812(11)230803(21)X11008
The hazard
A potential dose error exists for patients treated with an out of session SCINTIX partial fraction. The record states no specific incidents or injuries.
Context
GovInfoNow's records show Reflexion Medical, Inc. has had three other recalls since November 24, 2021. Other recent recalls include the Reflexion X1 Radiotherapy System Software Defect on February 9, 2026, and the Reflexion X1 Radiation Therapy System Recall on July 22, 2025. Similar product recalls include RayStation 10B Software on November 28, 2025.
How to tell if you have this one
Check for the software version 2.1.19-3 on your RefleXion X1 Radiotherapy System. Affected units have specific UDI codes listed in the recall notice.
Brand
Reflexion Medical
Product
RefleXion X1 Radiotherapy System Model RXM1000 Software version 2.1.19-3 Radiation therapy system is a device that
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Software Version
Verify your software version by checking the system settings or documentation.
Where it went and when
Where it was distributed
Distributed in 6 states.
Listed by the agency
Not listed
FDA distribution: “U.S.: CA, CT, NJ, OR, PA and TX No O.U.S.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: California, Connecticut, New Jersey, Oregon, Pennsylvania, Texas.
Recall timeline
FDA published this recall 50 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1933-2024 (April 16, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1933-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.