RayStation 6 Software Recall: Incorrect Radiation Dose Risk
RaySearch Laboratories recalls RayStation 6 software versions 6.0.0.24, 6.1.0.26, 6.1.1.2, and 6.2.0.7 due to potential incorrect radiation dose calculations during proton therapy QA checks.
Use caution until it’s fixed
For the proton QA preparation module in RayStation 6 (including SP1 and SP2), if the snout position or gap is modified in the QA module, the dose in the QA module may be computed for a different setup than what is used for QA measurements. This could result in an incorrect dosage being provided to a patient.
Contact the company
What happened, in plain English
RaySearch Laboratories is recalling specific versions of their RayStation 6 software used in radiation therapy treatment planning. The software may calculate incorrect radiation doses for patients if the snout position or gap settings are modified in the quality assurance module, which could lead to unsafe treatment outcomes. Read more at govinfonow.com/recall/73407-raystation-6-software-recall-incorrect-radiation-dose-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/73407-raystation-6-software-recall-incorrect-radiation-dose-risk · Updated September 20, 2026 · FDA enforcement record: FDA #Z-0380-2018
Cite this page
“RayStation 6 Software Recall: Incorrect Radiation Dose Risk.” GovInfoNow, updated September 20, 2026. https://govinfonow.com/recall/73407-raystation-6-software-recall-incorrect-radiation-dose-risk. Based on FDA recall #Z-0380-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0380-2018%22&limit=1).
Why it’s dangerous
If the snout position or gap settings are changed in the quality assurance module of RayStation 6, the software may compute radiation doses for a different treatment setup than what was actually used for measurements. This could result in patients receiving an incorrect radiation dose during their treatment.
Who’s affected
Healthcare professionals using RayStation 6 software for proton therapy treatment planning are most at risk. Patients receiving radiation therapy using these specific software versions could be affected if the software calculates incorrect doses.
How to tell if you have this one
Check if you have RayStation 6 software versions 6.0.0.24, 6.1.0.26, 6.1.1.2, or 6.2.0.7. These versions are used for proton therapy treatment planning and analysis in radiation therapy.
- Brand
RaySearch Laboratories- Category
Medical device
What to do — step by step
Check Software Version
Identify your RayStation 6 version by checking the software's version number in the application settings.
Update Software
Update to a newer version of RayStation 6 that is not listed in the recall to avoid the risk of incorrect dose calculations.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 7 states.
FDA distribution: “US Nationwide Distribution - FL, WA, AZ, TN, MD, TX, FL, MI, Washington D.C.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arizona, District of Columbia, Florida, Maryland, Michigan, Tennessee, Texas, Washington.
Recall timeline
FDA terminated this recall 13 months 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-0380-2018 (July 17, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0380-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 20, 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.