Lower riskMedical device recall · FDA · Published September 22, 2021
RayStation/RayPlan Software Versions 4-11A Recall: Unexpected Density Calculation Risk
RaySearch recalls software versions 4-11A with specific build numbers due to potential under/overestimation of radiation density in treatment planning. Affected users should check their version and contact RaySearch for updates.
An issue where the combined density in a dose grid voxel partially covered by the External ROI and also partially covered by an ROI of type Bolus, Support or Fixation may be unexpected.The density in the voxel can be both under- and overestimated
Take action
Contact the company
📍Recalling firmRAYSEARCH LABORATORIES ABSveavagen 9 · Stockholm, Sweden
✎ GovInfoNow plain-language explainer
RaySearch Laboratories is recalling specific versions of their radiation treatment planning software (RayStation and RayPlan) from versions 4 to 11A. The issue could lead to incorrect radiation dose calculations in treatment planning, potentially affecting patient safety. Users should check their software version and contact RaySearch for guidance. Read more at govinfonow.com/recall/61774-raystation-rayplan-software-versions-4-11a-recall-unexpected-density-calculation.
“RayStation/RayPlan Software Versions 4-11A Recall: Unexpected Density Calculation Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61774-raystation-rayplan-software-versions-4-11a-recall-unexpected-density-calculation. Based on FDA recall #Z-0849-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0849-2022%22&limit=1).
The FDA announced on September 22, 2021, that RaySearch Laboratories AB is recalling RayStation/RayPlan software versions 4 through 11A due to potential unexpected density calculations in dose grids. The agency classified the recall as Class II.
How to tell if you have it
Brand: RaySearch
Product: RayStation/RayPlan versions 4 - 11A, including service packs
The recall addresses an issue where combined density in a dose grid voxel partially covered by the External ROI and also partially covered by an ROI of type Bolus, Support or Fixation may be unexpected. The density in the voxel can be both under- and overestimated.
Context
GovInfoNow's records show RaySearch Laboratories AB has issued 36 other recalls since July 17, 2017. Recent brand recalls include a May 20, 2026 software recall for data loss risk and a November 28, 2025 recall for radiation dose calculation errors. Other recent recalls of similar products include an Elekta Leksell GammaPlan software recall on December 12, 2025, and an Elekta MOSAIQ Oncology System Software Recall on May 21, 2026.
How to tell if you have this one
Check your software version and build number. Affected versions include RayStation 4.0.0.14 through RayPlan 11.0.1.29 with specific build numbers listed in the recall notice.
Brand
RaySearch
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Your Software Version
Identify your RayStation or RayPlan version and build number to determine if it is affected by this recall.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “US Nationwide.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 6 months 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.
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-0849-2022 (September 22, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0849-2022 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.