Lower risk Medical device recall · FDA · Published January 22, 2021

RayStation software recall: Incorrect radiation treatment plans due to software bug

RaySearch America recalls RayStation software versions 8.1-10.1 for incorrect radiation treatment planning. The software bug may cause unsafe treatment plans if deep learning segmentation is used. Affected models include 8B, 8B SP1, 8B SP2, 9A, 9B, 9B SP1, 10A, 10A SP1, 10B.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2039-2023Medical device RaySearch America ›

Lower-risk recall

A software bug affecting results when using deep learning (DL) segmentation followed by geometrical functions: Create wall function, Expand Contract function or ROI algebra function, the results are incorrect. If dose statistics for an incorrectly created ROI are used to determine if a plan is acceptable for treatment, this could potentially lead to an inappropriate plan being approved. The error could lead to a more conservative or more liberal plan than intended.

Take action

Contact the company

Recalling firmRaySearch America Inc350 5th Ave Ste 5000, The Empire State Building · New York, NY 10118-0110

✎ GovInfoNow plain-language explainer

RaySearch America is recalling its RayStation radiation therapy software versions 8.1 through 10.1. The software bug can cause incorrect treatment plans when using deep learning segmentation features, potentially leading to unsafe radiation therapy. This affects medical professionals using the software for cancer treatment planning. Read more at govinfonow.com/recall/63355-raystation-software-recall-incorrect-radiation-treatment-plans-due-to-software.

Source Summary by GovInfoNow · govinfonow.com/recall/63355-raystation-software-recall-incorrect-radiation-treatment-plans-due-to-software · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2039-2023

Cite this page

“RayStation software recall: Incorrect radiation treatment plans due to software bug.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63355-raystation-software-recall-incorrect-radiation-treatment-plans-due-to-software. Based on FDA recall #Z-2039-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2039-2023%22&limit=1).

The FDA announced on Jan. 22, 2021, that RaySearch America Inc is recalling its RayStation standalone software treatment planning system due to a bug that can produce incorrect radiation therapy results. The agency issued recall number Z-2039-2023 for the voluntary Class II recall.

How to tell if you have it

Brand: RaySearch America
Product: RayStation standalone software treatment planning system
Model numbers: 8B, 8B SP1, 8B SP2, 9A, 9B, 9B SP1, 10A, 10A SP1 and 10B
Software versions: 8.1, 9.0, 9.1, 9.2, 10.0, 10.1
UDI-DI codes: 07350002010129, 07350002010204, 07350002010235, 07350002010174, 07350002010266, 07350002010297, 07350002010303, 07350002010365, 07350002010310
Distribution: AZ, CA, GA & WA
Units affected: 5 systems

The hazard

A software bug affecting results when using deep learning segmentation followed by geometrical functions can lead to incorrect outcomes. If dose statistics for an incorrectly created region of interest are used to determine plan acceptability, this could potentially lead to an inappropriate plan being approved. The error could result in a more conservative or liberal plan than intended.

Context

GovInfoNow's records show RaySearch America Inc has 1 other recall on record since Feb. 11, 2022. On Feb. 11, 2022, the company issued a RayStation software recall due to an incorrect dose calculation risk involving source to skin distance errors. Other recent recalls of similar products include RayStation Software Recalls (Nov. 28, 2025), RayStation 2024B Software Recall (Nov. 28, 2025) and RayStation/RayPlan Software Recall (Nov. 28, 2025).

How to tell if you have this one

Check if you have RayStation software versions 8.1, 9.0, 9.1, 9.2, 10.0, 10.1. The affected models include 8B, 8B SP1, 8B SP2, 9A, 9B, 9B SP1, 10A, 10A SP1, and 10B.

Brand
RaySearch America
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Software Version
Verify your RayStation software version by checking the software's version number in the settings menu.
Contact Manufacturer
Reach out to RaySearch America directly for assistance with the recall process.

Where it went and when

Where it was distributed

Distributed in 4 states.

FDA distribution: “US: AZ, CA, GA & WA” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Arizona, California, Georgia, Washington.

Recall timeline

FDA terminated this recall 2.4 years after the firm started it.

Jan 22, 2021Firm started the recall
Jun 29, 2023FDA classified it Class II
Jul 3, 2023FDA terminated the recall
Jul 5, 2023Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/63355-raystation-software-recall-incorrect-radiation-treatment-plans-due-to-software">RayStation software recall: Incorrect radiation treatment plans due to software bug (GovInfoNow)</a>

Where this comes from

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-2039-2023 (January 22, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2039-2023 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.