Lower riskMedical device recall · FDA · Published June 1, 2022
RayStation 9B SP1 Radiation Treatment Software Recall: Information Not Propagating
RaySearch Laboratories recalls RayStation 9: Information may not propagate from RayTreat to RayCare during some workflows. Affected units: 9B SP1 software version 9.2.0.483. No remedy specified in recall notice.
An issue with propagation of treatment course information from RayStation with RayTreat to RayCare has been identified. During some workflows, information may not be propagated to RayCare.
Take action
Contact the company
📍Recalling firmRAYSEARCH LABORATORIES ABSveavagen 9 · Stockholm, Sweden
“RayStation 9B SP1 Radiation Treatment Software Recall: Information Not Propagating.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/60567-raystation-9b-sp1-radiation-treatment-software-recall-information-not-propagating. Based on FDA recall #Z-1403-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1403-2022%22&limit=1).
The FDA announced on June 1, 2022, that RaySearch Laboratories AB voluntarily recalled RayStation 9B SP1 radiation treatment planning software due to a data propagation issue. The agency classified the recall as Class II.
How to tell if you have it
Brand: RaySearch Laboratories
Product: RayStation 9B SP1
Build number: 9.2.0.483
UDI-DI: 0735000201029720200310
The hazard
According to the FDA, an issue with propagation of treatment course information from RayStation with RayTreat to RayCare has been identified. During some workflows, information may not be propagated to RayCare.
Context
GovInfoNow's records show RaySearch Laboratories AB has issued 36 other recalls since July 17, 2017. Recent brand recalls include RayCare 2:024A SP1 on May 20, 2026, and RayStation Software Version 12A on November 28, 2025. Other recent recalls of similar products include Elekta Leksell GammaPlan 11.1 Software Recall (December 12, 2025), Elekta MOSAIQ Oncology System Software Recall (May 21, 2026), and Elekta Leksell GammaPlan software version 11.3/11.4 recall (December 12, 2025).
How to tell if you have this one
Check for RayStation 9B SP1 software version 9.2.0.483. The product is used for radiation treatment planning and sold with UDI-DI: 0735000201029720200310.
Brand
RaySearch Laboratories
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Software Version
Verify your RayStation software version is 9.2.0.483 for the 9B SP1 model.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide distribution - US Nationwide distribution in the state of TN and the countries of Belgium and Switzerland.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 16 months 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 addresses a potential error in data transfer between systems, but no immediate safety risk is described. The hazard is low risk as it does not cause physical injury.
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-1403-2022 (June 1, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1403-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 10, 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.