Use cautionMedical device recall · FDA · Published July 22, 2025
Reflexion X1 Radiation Therapy System Recall: Software Issue May Cause Toxicity
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.
Due to incorrect software configuration that potentially allows more than two (2) fractions within a 12-hour period (fractionLimits) and could potentially lead to adverse events (toxicity).
Take action
Contact the company
📍Recalling firmReflexion Medical, Inc.25881 Industrial Blvd · Hayward, CA 94545-2991
“Reflexion X1 Radiation Therapy System Recall: Software Issue May Cause Toxicity.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/51760-reflexion-x1-radiation-therapy-system-recall-software-issue-may-cause. Based on FDA recall #Z-2486-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2486-2025%22&limit=1).
The FDA announced on July 22, 2025, that Reflexion Medical, Inc. is recalling its RefleXion X1 Model RXM1000 radiation therapy systems due to a software configuration error that could lead to toxicity. The agency reported the Class II recall of 11 units distributed nationwide.
According to the FDA, the recall is due to an incorrect software configuration that potentially allows more than two fractions within a 12-hour period. This error could potentially lead to adverse events, including toxicity.
Context
GovInfoNow's records show Reflexion Medical, Inc. has issued three other recalls since November 24, 2021, including software defect and dose discrepancy issues on February 9, 2026, April 16, 2024, and November 24, 2021. Other recent recalls of similar products include RayStation/RayPlan Software Recall: Radiation Dose Calculation Errors (November 28, 2025) and RayStation/RayPlan Software 11A Recalls: Radiation Dose Calculation Risk (November 28, 2025).
How to tell if you have this one
Check the UDI codes on your device. Affected units have specific serial numbers starting with (01)00860003983812 followed by a date code and model number (e.g., (11)230504(21)X11001).
Brand
Reflexion Medical
Product
RefleXion X1 Model RXM1000 UDI Codes: (01)00860003983812(11)230504(21)X11001 (01)00860003983812(11)230518(21)X11002
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Device UDI Codes
Look for the unique device identifier codes on your RefleXion X1 model. Affected units have specific UDI codes listed in the recall notice.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 7 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “U.S. Nationwide distribution in the states of CA, CT, LA, NJ, OR, PA, and TX.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, Connecticut, Louisiana, 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.
No, but you should check the UDI codes to see if your device is affected. The recall does not require immediate discontinuation but requires verification of the device's serial number.
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-2486-2025 (July 22, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2486-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 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.