RayStation radiation treatment software recalled due to incorrect beam setup
RaySearch Laboratories recalls RayStation versions 9A-11A with incorrect beam delivery positions. Affected software versions may cause treatment errors if used without correction.
Lower-risk recall
Initial delivery positions will be set incorrectly when having setup beam(s) at the localization point.
Contact the company
What happened, in plain English
RaySearch Laboratories is recalling several versions of their radiation treatment planning software (RayStation 9A, 9B, 9B SP1, 10A, 10A SP1, 10B, 11A) because initial beam setup positions can be incorrect. This could lead to improper radiation treatment delivery if the software is used without correction. Read more at govinfonow.com/recall/62370-raystation-radiation-treatment-software-recalled-due-to-incorrect-beam-setup.
Source Summary by GovInfoNow · govinfonow.com/recall/62370-raystation-radiation-treatment-software-recalled-due-to-incorrect-beam-setup · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2138-2021
Cite this page
“RayStation radiation treatment software recalled due to incorrect beam setup.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62370-raystation-radiation-treatment-software-recalled-due-to-incorrect-beam-setup. Based on FDA recall #Z-2138-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2138-2021%22&limit=1).
Why it’s dangerous
The software may set radiation beam positions incorrectly during initial setup at the localization point. This could result in improper radiation delivery to patients during treatment. The hazard is specific to the software's configuration process and not a general safety issue.
Who’s affected
Healthcare providers using RayStation software for radiation treatment planning are most at risk. Patients receiving treatment with affected versions may experience incorrect radiation delivery.
How to tell if you have this one
Check if your software version matches the listed build numbers: RayStation 9.0 (9.0.0.113), 9.1 (9.1.0.933), 9.1 SP1 (9.2.0.483), 10.0 (10.0.0.1154), 10.0 SP1 (10.0.1.52), 10.1 (10.1.0.613), or 11.0 (11.0.0.951).
- Brand
RaySearch Laboratories- Category
Medical device
What to do — step by step
Check Software Version
Verify your RayStation version against the listed build numbers to confirm if it is affected.
Where it went and when
Where it was distributed
Distributed in Tennessee, and outside the U.S.
FDA distribution: “US distribution to TN; and Belgium” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Tennessee.
Recall timeline
FDA terminated this recall 2.8 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-2138-2021 (June 8, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2138-2021 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.