Lower riskMedical device recall · FDA · Published June 10, 2022
RayStation 11B Software Display Errors: Misleading LET Values
RaySearch Laboratories recalls RayStation 11B software versions 12.0.0.932, 12.1.0.1221, 12.0.3.68 due to potential misleading Linear Energy Transfer (LET) displays in dose evaluations and beam-specific distributions.
This notice concerns two issues found related to the display of Linear Energy Transfer (LET) in RayStation 11B including some service packs. First, when using a dose threshold for an evaluation dose, LET display might be misleading. Second, a displayed beam-specific LET distribution can sometimes be out of sync with the selected beam.
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📍Recalling firmRAYSEARCH LABORATORIES ABSveavagen 9 · Stockholm, Sweden
✎ GovInfoNow plain-language explainer
RaySearch Laboratories is recalling specific versions of their RayStation 11B software. These versions may show inaccurate Linear Energy Transfer (LET) values, which could lead to incorrect radiation treatment planning in medical imaging. This matters because precise LET measurements are critical for safe and effective radiation therapy. Read more at govinfonow.com/recall/60516-raystation-11b-software-display-errors-misleading-let-values.
“RayStation 11B Software Display Errors: Misleading LET Values.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/60516-raystation-11b-software-display-errors-misleading-let-values. Based on FDA recall #Z-1299-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1299-2022%22&limit=1).
The FDA announced on June 10, 2022, that RaySearch Laboratories AB is recalling RayStation 11B software due to potential misleading Linear Energy Transfer displays. The agency issued recall number Z-1299-2022 for the Class II device.
According to the FDA, the recall concerns two issues with Linear Energy Transfer (LET) display in RayStation 11B and some service packs. First, using a dose threshold for an evaluation dose may result in misleading LET displays. Second, a displayed beam-specific LET distribution can sometimes be out of sync with the selected beam.
Context
GovInfoNow's records show that RaySearch Laboratories AB has had 36 other recalls on record since July 17, 2017. Recent brand recalls include a May 20, 2026 notice for RayCare 2:024A SP1 Oncology Software regarding data loss risk and an Nov. 28, 2025 recall of RayStation/RayPlan 10B software for radiation dose calculation risks. Other recent recalls of similar products include Elekta Leksell GammaPlan 11.1 Software Recall (Dec. 12, 2025) and Boston Scientific TheraSphere 360 Y-90 Software Anomaly Recall (June 19, 2026).
How to tell if you have this one
Check if your RayStation 11B software version is 12.0.0.932, 12.1.0.1221, or 12.0.3.68. The software version numbers are listed in the product description.
Brand
RaySearch Laboratories
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Software Version
Verify your RayStation 11B software version by checking the version numbers listed in the product description.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 2 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution in the states of NJ and TX.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: New Jersey, Texas.
Recall timeline
FDA terminated this recall 2 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
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-1299-2022 (June 10, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1299-2022 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.