Lower riskMedical device recall · FDA · Published November 20, 2017
RayStation software versions with dose calculation errors
RaySearch Laboratories recalls specific RayStation software versions due to potential dose calculation errors in radiation therapy planning. Affected versions include 3.5 through 6.2.
When calculating electron Monte Carlo dose with a very large number of histories, the dose calculation may be wrong
Take action
Contact the company
📍Recalling firmRAYSEARCH LABORATORIES ABSveavagen 9 · Stockholm, Sweden
✎ GovInfoNow plain-language explainer
RaySearch Laboratories is recalling several versions of their RayStation and RayPlan software used in radiation therapy planning. The software may calculate radiation doses incorrectly when using very large numbers of simulation histories, which could lead to unsafe treatment plans. Read more at govinfonow.com/recall/72510-raystation-software-versions-with-dose-calculation-errors.
“RayStation software versions with dose calculation errors.” GovInfoNow, updated September 1, 2026. https://govinfonow.com/recall/72510-raystation-software-versions-with-dose-calculation-errors. Based on FDA recall #Z-1930-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1930-2019%22&limit=1).
The FDA announced on November 20, 2017, that RaySearch Laboratories AB is recalling RayStation and RayPlan software due to potential incorrect electron Monte Carlo dose calculations. According to the FDA, owners should contact the company for a remedy.
According to the FDA, when calculating electron Monte Carlo dose with a very large number of histories, the dose calculation may be wrong.
Context
GovInfoNow's records show RaySearch Laboratories AB has had 36 other recalls on record since July 17, 2017. Recent similar recalls include the RayCare 2:024A SP1 Oncology Software Data Loss Risk (May 20, 2026), the RayStation 2024B Software Recall for Radiation Dose Calculation Errors (November 28, 2025), and the RayStation 10B Software Version 10.1.0.613 DICOM UID Not Unique Risk (August 8, 2025). Other recent recalls of similar products include the Boston Scientific TheraSphere 360 Y-90 Software Anomaly Recall (June 19, 2026) and the Elekta Leksell GammaPlan software version 11.3/11.4 recall for Risk of incorrect patient irradiation (December 12, 2025).
How to tell if you have this one
Check if you own RayStation software versions 3.5.0.16 through 6.2.0.7 as listed in the recall notice. The software is used for radiation therapy treatment planning in medical facilities.
Brand
RaySearch Laboratories
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Software Version
Identify your RayStation software version by checking the version numbers listed in the recall notice.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “US Nationwide Distribution” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 5.7 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 recall indicates a potential for incorrect dose calculations in specific scenarios, but the risk is low and does not require immediate action for most users.
How can I check if my software is affected?
Check your software version against the list of affected versions provided in the recall notice, which includes versions from 3.5.0.16 through 6.2.0.7.
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-1930-2019 (November 20, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1930-2019 to see it in context.
Plain-language summary written by qwen3:4b on September 1, 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.