Lower riskMedical device recall · FDA · Published February 17, 2023
Raystation treatment planning system recall: Incorrect collimator angle in exported plans
Raysearch recalls Raystation radiation therapy software versions 9.0.0-13.1.0 with incorrect collimator angle in exported DICOM plans. Users may need to update software to prevent treatment errors.
It is possible to set a non-zero collimator angle in the Virtual Simulation module. The angle will be correct in the user interface but if the plan is DICOM exported by using the VSIM Export button, the angle will not be correct in the exported RT plan. In the exported RT plan, the DICOM attribute Beam Limiting Device Angle (300A,0120) is set to zero, regardless of the selected collimator angle.
Take action
Contact the company
📍Recalling firmRAYSEARCH LABORATORIES ABEugeniavagen 18c · Stockholm, Sweden
“Raystation treatment planning system recall: Incorrect collimator angle in exported plans.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/58873-raystation-treatment-planning-system-recall-incorrect-collimator-angle-in-exported. Based on FDA recall #Z-1281-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1281-2023%22&limit=1).
The FDA announced on Feb. 17, 2023, that Raysearch Laboratories AB is recalling Raystation treatment planning systems for radiation therapy due to a hazard involving incorrect collimator angles in exported plans. The agency said the recall affects 10,770 systems distributed nationwide.
Software Version Numbers: 9A, 9B, 10A, 10B, 11A, 11B and 12A including service packs
UDI-DI: 0735000201067920221007
The hazard
The FDA said it is possible to set a non-zero collimator angle in the Virtual Simulation module that appears correct in the user interface but is incorrect in the DICOM-exported RT plan. Specifically, the DICOM attribute Beam Limiting Device Angle (300A,0120) is set to zero regardless of the selected collimator angle when using the VSIM Export button.
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 RayCare 2:024A SP1 Oncology Software recall for data loss risk and a Nov. 28, 2025 RayStation/RayPlan 10B Software Recall for radiation dose calculation risks. Other recent recalls of similar products include an Dec. 12, 2025 Elekta Leksell GammaPlan 11.1 Software Recall and a Feb. 6, 2026 Hitachi Proton Beam Therapy System Recall.
How to tell if you have this one
Check if your Raystation software version is listed in the model numbers 9.0.0 through 13.1.0 or software versions 9A through 12B. The recall includes specific UDI-DI numbers starting with 0735000201067920221007.
Brand
Raysearch
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Software Version
Verify your Raystation version by checking the software version number in the program interface or documentation.
Update Software
Install the latest software update from Raysearch to fix the collimator angle issue in exported plans.
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 40 days 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-1281-2023 (February 17, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1281-2023 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.