Lower risk Medical device recall · FDA · Published February 23, 2024

RayStation Software Versions 8B-2024A: Material Override Risk

RaySearch recalls software versions 8B through 2024A due to risk of incorrect silicone implant material selection in treatment planning.

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

🇺🇸 FDA recall #Z-1482-2024Medical device RaySearch ›

Lower-risk recall

A use error that has occurred with RayStation/RayPlan, where material override using Silicon, Si, was incorrectly selected for a silicone gel polymer implant.

Take action

Contact the company

Recalling firmRAYSEARCH LABORATORIES ABEugeniavagen 18c · Stockholm, Sweden

✎ GovInfoNow plain-language explainer

RaySearch Laboratories is recalling specific versions of their RayStation software because a use error could cause incorrect selection of silicone implant material during treatment planning. This could lead to improper treatment of patients with silicone gel polymer implants. Read more at govinfonow.com/recall/56097-raystation-software-versions-8b-2024a-material-override-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/56097-raystation-software-versions-8b-2024a-material-override-risk · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1482-2024

Cite this page

“RayStation Software Versions 8B-2024A: Material Override Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/56097-raystation-software-versions-8b-2024a-material-override-risk. Based on FDA recall #Z-1482-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1482-2024%22&limit=1).

The FDA announced on Feb. 23, 2024, that RaySearch Laboratories AB is recalling RayStation software versions 8B through 2024A due to a use error hazard. The agency said the software may incorrectly select Silicon as the material override for silicone gel polymer implants.

How to tell if you have it

Brand: RaySearch
Product: RayStation Software
Versions: 8B, 9A, 9B, 10A, 10B, 11A, 11B, 12A, 12B, 2023B, 2024A including service packs
Units affected: 154

The hazard

According to the FDA, a use error has occurred where material override using Silicon was incorrectly selected for a silicone gel polymer implant during RayStation/RayPlan use.

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 recalls (Dec. 12, 2025) and a Hitachi Proton Beam Therapy System recall (Feb. 6, 2026).

How to tell if you have this one

Check your RayStation software version numbers (e.g., 8B, 9A, 10A) in the software's version history or help menu. The affected versions include specific build numbers listed in the recall notice.

Brand
RaySearch
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Software Version
Review your RayStation software version number to confirm if it is among the recalled versions (8B, 9A, 9B, 10A, 10B, 11A, 11B, 12A, 12B, 2023B, 2024A).

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Worldwide distribution - US Nationwide and the countries of Australia, Austria, Bahrain, Belgium, Canada, Colombia, Cyprus, Czech Republic, Denmark, Egypt, Estonia, France, Germany, Hong Kong S.A.R., Hungary, India, Indonesia, Israel,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA published this recall 54 days after the firm started it.

Feb 23, 2024Firm started the recall
Apr 5, 2024FDA classified it Class II
Apr 17, 2024Published in FDA’s Enforcement Report

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

Similar recalls

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Keep exploring

More RaySearch recalls

Link to this recall

<a href="https://govinfonow.com/recall/56097-raystation-software-versions-8b-2024a-material-override-risk">RayStation Software Versions 8B-2024A: Material Override 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-1482-2024 (February 23, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1482-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 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.