Lower risk Medical device recall · FDA · Published September 21, 2018

RayStation Software Recalled: Robust Optimization Not Supported

RaySearch Laboratories recalls RayStation software versions 4.5 to 7 due to unsupported robust optimization for treatment plans. Affected users should contact for updates.

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

🇺🇸 FDA recall #Z-0294-2019Medical device RaySearch Laboratories ›

Lower-risk recall

Robust optimization for plans using beam set + background dose is not supported in RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6 and RayStation 7.

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 treatment planning software. The issue means these versions don't support robust optimization for radiation treatment plans, which could affect treatment accuracy. Read more at govinfonow.com/recall/69832-raystation-software-recalled-robust-optimization-not-supported.

Source Summary by GovInfoNow · govinfonow.com/recall/69832-raystation-software-recalled-robust-optimization-not-supported · Updated August 20, 2026 · FDA enforcement record: FDA #Z-0294-2019

Cite this page

“RayStation Software Recalled: Robust Optimization Not Supported.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69832-raystation-software-recalled-robust-optimization-not-supported. Based on FDA recall #Z-0294-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0294-2019%22&limit=1).

The FDA announced on 2018-09-21 that RaySearch Laboratories AB is recalling RayStation 4.5, 4.7, 5, 6 and 7 stand-alone software treatment planning systems due to a hazard involving unsupported robust optimization for plans using beam set + background dose. The recall affects 110 units distributed nationwide.

How to tell if you have it

Brand: RaySearch Laboratories
Product names: RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6 and RayStation 7
Software versions: 4.5.0.19, 4.5.1.14, 4.5.2.7, 4.7.0.15, 4.7.1.10, 4.7.2.5, 4.7.3.13, 4.7.4.4, 4.7.5.4, 5.0.0.37, 5.0.1.11, 5.0.2.3, 6.0.0.24, 6.1.0.26, 6.1.1.2, 6.2.0.7, 7.0.0.19
Units affected: 110

The hazard

The hazard involves robust optimization for plans using beam set + background dose not being supported in the recalled software versions.

Context

GovInfoNow's records show RaySearch Laboratories AB has issued 36 other recalls since 2017-07-17, including a 2026-05-20 recall for RayCare 2:024A SP1 Oncology Software Data Loss Risk and a 2025-11-28 recall for RayStation 2024B Software Radiation Dose Calculation Errors. Other recent recalls of similar products include Elekta MOSAIQ Oncology System Software Recall (2026-05-21), Elekta Leksell GammaPlan 11.1 Software Recall (2025-12-12) and Hitachi Proton Beam Therapy System Recall (2026-02-06).

How to tell if you have this one

Check if you have RayStation software versions 4.5.0.19, 4.5.1.14, 4.5.2.7, 4.7.0.15, 4.7.1.10, 4.7.2.5, 4.7.3.13, 4.7.4.4, 4.7.5.4, 5.0.0.37, 5.0.1.11, 5.0.2.3, 6.0.0.24, 6.1.0.26, 6.1.1.2, 6.2.0.7, or 7.0.0.19.

Brand
RaySearch Laboratories
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Software Version
Identify your RayStation version by checking the software's version number.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 21 months after the firm started it.

Sep 21, 2018Firm started the recall
Oct 30, 2018FDA classified it Class II
Nov 7, 2018Published in FDA’s Enforcement Report
Jun 16, 2020FDA 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 there a risk of injury from this software?

The recall is for potential treatment inaccuracies, not immediate safety hazards. The risk level is low.

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Link to this recall

<a href="https://govinfonow.com/recall/69832-raystation-software-recalled-robust-optimization-not-supported">RayStation Software Recalled: Robust Optimization Not Supported (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-0294-2019 (September 21, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0294-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 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.