Lower risk Medical device recall · FDA · Published November 11, 2020

RaySearch RayStation and RayPlan Software Recalls: Incorrect Treatment Plan Reports

RaySearch recalls specific versions of RayStation and RayPlan software due to potential incorrect treatment plan reports, which could affect radiation therapy accuracy. Affected users should check their software versions.

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

🇺🇸 FDA recall #Z-0589-2021Medical device RaySearch ›

Lower-risk recall

Two issues were found with the treatment plan report: 1) There may be incorrect information for the percent of a region of interest with a clinical goal that is outside the dose grid; and 2) For RayStation and RayPlan 9B and 10A, 6D couch angles may be incorrect.

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Contact the company

Recalling firmRAYSEARCH LABORATORIES ABSveavagen 9 · Stockholm, Sweden

✎ GovInfoNow plain-language explainer

RaySearch Laboratories is recalling specific versions of RayStation and RayPlan software because they may contain errors in treatment plan reports. These errors could lead to incorrect radiation dosing during cancer treatment, potentially affecting patient safety. Read more at govinfonow.com/recall/63940-raysearch-raystation-and-rayplan-software-recalls-incorrect-treatment-plan-reports.

Source Summary by GovInfoNow · govinfonow.com/recall/63940-raysearch-raystation-and-rayplan-software-recalls-incorrect-treatment-plan-reports · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0589-2021

Cite this page

“RaySearch RayStation and RayPlan Software Recalls: Incorrect Treatment Plan Reports.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63940-raysearch-raystation-and-rayplan-software-recalls-incorrect-treatment-plan-reports. Based on FDA recall #Z-0589-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0589-2021%22&limit=1).

The FDA announced on November 11, 2020, that RaySearch Laboratories AB voluntarily recalled RayStation and RayPlan software versions due to potential incorrect information in treatment plan reports. The agency issued recall number Z-0589-2021 for the Class II device.

How to tell if you have it

Brand: RaySearch
Product: RayStation (versions 4, 4.5, 4.7, 4.9, 5, 6, 7, 8A, 8B, 9A, 9B, 10A)
Product: RayPlan (versions 1, 2, 7, 8A, 8B, 9A, 9B, 10A)
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: 124

The hazard

According to the FDA, two issues were found with the treatment plan report. First, there may be incorrect information for the percent of a region of interest with a clinical goal that is outside the dose grid. Second, for RayStation and RayPlan 9B and 10A, 6D couch angles may be incorrect.

Context

GovInfoNow's records show RaySearch Laboratories AB has 36 other recalls on record since July 17, 2017. Other recent recalls of similar products include Elekta Leksell GammaPlan 11.1 Software Recall (December 12, 2025), Elekta Leksell GammaPlan software version 11.3/11.4 recall (December 12, 2025), and Elekta MOSAIQ Oncology System Software Recall (May 21, 2026).

How to tell if you have this one

Check if your software version matches the listed versions (e.g., RayStation 4.0, 4.5, 4.7, 4.9, 5.0, etc.) or the specific software version numbers provided in the recall. The recall includes all service packs for these versions.

Brand
RaySearch
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Software Version
Review your RayStation or RayPlan software version to see if it matches the affected versions listed in the recall.

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.

Nov 11, 2020Firm started the recall
Dec 15, 2020FDA classified it Class II
Dec 23, 2020Published in FDA’s Enforcement Report
May 9, 2023FDA terminated the recall

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

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Keep exploring

More RaySearch recalls

Link to this recall

<a href="https://govinfonow.com/recall/63940-raysearch-raystation-and-rayplan-software-recalls-incorrect-treatment-plan-reports">RaySearch RayStation and RayPlan Software Recalls: Incorrect Treatment Plan Reports (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-0589-2021 (November 11, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0589-2021 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.