Reflexion Medical RXM1000 Radiotherapy System Recall: Dose Discrepancy in Feet First
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.
Use caution until it’s fixed
Due to dose discrepancy when delivering a plan to a patient in a Non-HFS (Head First Supine) orientation specifically in Feet First Supine (FFS).
Contact the company
What happened, in plain English
Reflexion Medical is recalling its RXM1000 radiotherapy systems because they can deliver incorrect radiation doses when treating patients in a Feet First Supine (FFS) position. This could lead to improper treatment and potential health risks if not corrected. Read more at govinfonow.com/recall/61503-reflexion-medical-rxm1000-radiotherapy-system-recall-dose-discrepancy-in-feet.
Source Summary by GovInfoNow · govinfonow.com/recall/61503-reflexion-medical-rxm1000-radiotherapy-system-recall-dose-discrepancy-in-feet · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0470-2022
Cite this page
“Reflexion Medical RXM1000 Radiotherapy System Recall: Dose Discrepancy in Feet First.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61503-reflexion-medical-rxm1000-radiotherapy-system-recall-dose-discrepancy-in-feet. Based on FDA recall #Z-0470-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0470-2022%22&limit=1).
Why it’s dangerous
The system may deliver incorrect radiation doses when treating patients in a Feet First Supine (FFS) orientation. This dose discrepancy could result in improper treatment and potential health risks if the error is not corrected.
Who’s affected
Healthcare providers using the RefleXion RXM1000 radiotherapy system for cancer treatment are most at risk. Patients receiving treatment in Feet First Supine positions may be affected.
How to tell if you have this one
Check for the system label: "*** refleXion REF RXM1000 ***" on the device. Affected units have specific serial numbers starting with X11001, X11002, or X11003.
- Brand
Reflexion Medical- Product
RefleXion Medical Radiotherapy System - System Label: "*** refleXion REF RXM1000 ***" Physics Guide/Treatment Delivery- Category
Medical device
What to do — step by step
Check System Label
Look for the label: "*** refleXion REF RXM1000 ***" on the device.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 2 states.
FDA distribution: “U.S. Nationwide distribution in the states of CA and TX” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, Texas.
Recall timeline
FDA terminated this recall 2.6 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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-0470-2022 (November 24, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0470-2022 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 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.