RayStation 11.0.x Versions Risk of High SSD Values - Recall

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Recalling firmRAYSEARCH LABORATORIES ABEugeniavagen 18c · Stockholm, N/A

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✎ GovInfoNow plain-language explainer

What happened, in plain English

RaySearch Laboratories is recalling several versions of their RayStation radiation therapy software. The recall is due to a potential issue where the system might report an SSD (safety distance) value that is too high, which could lead to inaccurate treatment planning in radiation therapy.

Why it’s dangerous

The software may report an SSD (safety distance) value that is too high. This could result in inaccurate radiation treatment planning, potentially affecting patient safety during radiation therapy procedures.

Who’s affected

Healthcare professionals using RaySearch RayStation software for radiation therapy planning are affected. Those who have the specific software versions listed in the recall are most at risk.

How to tell if you have this one

Check if you have RayStation software versions 11.0.0.951, 11.0.1.29, 11.0.3.116, or 11.0.4.15. These versions were sold between 2021 and 2022.

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 in the system settings.

✎ GovInfoNow

Questions people ask

What versions of RayStation are affected?

RayStation 11.0.0.951, 11.0.1.29, 11.0.3.116, and 11.0.4.15 are affected.

How can I tell if I have the recalled software?

Check your software version in the system settings. The affected versions were sold between 2021 and 2022.

What should I do if I have the recalled software?

The recall does not specify a remedy, so you should check your software version and contact RaySearch Laboratories for further guidance.

Take action

Contact RaySearch Laboratories

We’ve drafted a message you can send RaySearch Laboratories to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-1748-2024 — RaySearch Laboratories RaySearch Laboratories

Hello,

I own a RaySearch Laboratories that is covered by recall Z-1748-2024 from RaySearch Laboratories.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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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-1748-2024 (March 28, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1748-2024 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.

RAYSEARCH LABORATORIES AB recalls RayStation 11.0.0.951, 11.0.1.29, 11.0.3.116 & 11.0.4.15. Radiation Therapy Treatment Planning System.

Lower-risk recall