Lower risk Medical device recall · FDA · Published October 8, 2020

RayStation Software Recalls: Missing ROI/POI Reference Risk

RaySearch recalls specific software versions for radiation therapy planning due to potential incorrect reference links in imported treatment plans. Affected users should check version numbers and contact RaySearch for guidance.

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

🇺🇸 FDA recall #Z-0478-2021Medical device RaySearch ›

Lower-risk recall

If a region of interest (ROI) or point of interest (POI) that is referenced from an imported plan is missing in the imported RT Structure Set, the reference may become linked to the wrong ROI or POI.

Take action

Contact the company

Recalling firmRAYSEARCH LABORATORIES ABSveavagen 9 · Stockholm, Sweden

✎ GovInfoNow plain-language explainer

RaySearch Laboratories recalls several versions of their RayStation software for radiation treatment planning. The issue could cause imported treatment plans to link to the wrong regions or points of interest, potentially leading to incorrect radiation delivery. This is a software problem that affects medical professionals using the system. Read more at govinfonow.com/recall/64108-raystation-software-recalls-missing-roi-poi-reference-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/64108-raystation-software-recalls-missing-roi-poi-reference-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0478-2021

Cite this page

“RayStation Software Recalls: Missing ROI/POI Reference Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64108-raystation-software-recalls-missing-roi-poi-reference-risk. Based on FDA recall #Z-0478-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0478-2021%22&limit=1).

The FDA announced on Oct. 8, 2020, that RaySearch Laboratories AB voluntarily recalled its RayStation standalone software treatment planning system due to potential incorrect linking of regions of interest. This Class II recall affects 2,768 units distributed nationwide.

How to tell if you have it

Brand: RaySearch
Product: RayStation standalone software treatment planning system
Model Numbers: 4.0, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1, 6.2, 6.3, 7.0, 8.0, 8.1, 9.0, 9.1, 9.2, 10.0
Software Versions: 4.0.0.14, 4.0.3.4, 4.5.1.14, 4.7.2.5, 4.7.3.13, 4.7.4.4, 4.7.5.4, 4.7.6.7, 4.9.0.42, 5.0.1.11, 5.0.2.35, 5.0.3.17, 6.0.0.24, 6.1.1.2, 6.2.0.7, 6.3.0.6, 7.0.0.19, 8.0.0.61, 8.0.1.10, 8.1.0.47, 8.1.1.8, 8.1.2.5, 9.0.0.113, 9.1.0.933, 9.2.0.483, 10.0.0.1154
Units Affected: 2768

The hazard

According to the FDA, if a region of interest (ROI) or point of interest (POI) referenced from an imported plan is missing in the imported RT Structure Set, the reference may become linked to the wrong ROI or POI.

Context

GovInfoNow's records show RaySearch Laboratories AB has issued 36 other recalls since July 17, 2017. Other recent recalls of similar products include Elekta Leksell GammaPlan software version 11.3/11.4 recall (Dec. 12, 2025) and Hitachi Proton Beam Therapy System Recall (Feb. 6, 2026).

How to tell if you have this one

Check if you have RayStation software versions 4.0, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1, 6.2, 6.3, 7.0, or newer versions listed in the product details. The software is used for radiation therapy treatment planning in medical settings.

Brand
RaySearch
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 product details.

Where it went and when

Where it was distributed

Distributed nationwide.

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 2.5 years after the firm started it.

Oct 8, 2020Firm started the recall
Nov 20, 2020FDA classified it Class II
Dec 2, 2020Published in FDA’s Enforcement Report
Mar 30, 2023FDA terminated the recall

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

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Is this a safety hazard?

This is a potential issue with imported treatment plans that could lead to incorrect references, but it is not a safety hazard that requires immediate action.

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Link to this recall

<a href="https://govinfonow.com/recall/64108-raystation-software-recalls-missing-roi-poi-reference-risk">RayStation Software Recalls: Missing ROI/POI Reference Risk (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-0478-2021 (October 8, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0478-2021 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.