Lower risk Medical device recall · FDA · Published May 26, 2020

RayStation Software Recalled: Treatment Data Import Errors

RaySearch Laboratories recalls RayStation software versions 8A-9B due to potential treatment data import errors in radiation therapy systems. Affected users should check their software version and contact support for updates.

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

🇺🇸 FDA recall #Z-2426-2020Medical device RaySearch Laboratories ›

Lower-risk recall

It is not obvious that the manual import of a treatment record into RayCare PACS does not automatically import the same data into RayTreat. In addition, there is an issue found with the display of planned and recorded Gantry Angle in the delivered beam list in RayTreat.

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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 their RayStation treatment planning software because importing treatment records into PACS may not correctly transfer data to RayTreat. This could lead to incorrect radiation therapy planning if not addressed. Read more at govinfonow.com/recall/65095-raystation-software-recalled-treatment-data-import-errors.

Source Summary by GovInfoNow · govinfonow.com/recall/65095-raystation-software-recalled-treatment-data-import-errors · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2426-2020

Cite this page

“RayStation Software Recalled: Treatment Data Import Errors.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/65095-raystation-software-recalled-treatment-data-import-errors. Based on FDA recall #Z-2426-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2426-2020%22&limit=1).

The FDA announced on May 26, 2020, that RaySearch Laboratories AB is recalling RayStation standalone software treatment planning systems (versions 8A, 8B, 9A, and 9B) due to data import and display errors. According to the FDA, the hazard involves manual treatment records not automatically importing into RayTreat and incorrect Gantry Angle displays.

How to tell if you have it

Brand: RaySearch Laboratories
Product: RayStation standalone software treatment planning system
Models: RayStation 8A, 8B, 9A, and 9B (including all service packs)
Model numbers: 8.0, 8.1, 9.0, 9.1, 9.2
Software versions: 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, and 9.2.0.483
Units affected: 12

The hazard

According to the FDA, it is not obvious that the manual import of a treatment record into RayCare PACS does not automatically import the same data into RayTreat. Additionally, there is an issue with the display of planned and recorded Gantry Angle in the delivered beam list in RayTreat.

Context

GovInfoNow's records show RaySearch Laboratories AB has issued 36 other recalls since July 17, 2017. Recent recalls include the May 20, 2026 RayCare 2:024A SP4 Oncology Software Data Loss Risk and the November 28, 2025 RayStation 10B Software recall for potential radiation dose errors. Other recent recalls of similar products include the December 12, 2025 Elekta Leksell GammaPlan 11.1 Software Recall and the May 21, 2026 Elekta MOSAIQ Oncology System Software Recall.

How to tell if you have this one

Check your RayStation software version number. Affected versions include 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, and 9.2.0.483. The software was sold with model numbers 8.0, 8.1, 9.0, 9.1, and 9.2.

Brand
RaySearch Laboratories
Category
Medical device

Based on the official FDA remedy

What to do — step by step

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

How this recall unfolded

Recall timeline

FDA published this recall 36 days after the firm started it.

May 26, 2020Firm started the recall
Jun 24, 2020FDA classified it Class II
Jul 1, 2020Published in FDA’s Enforcement Report

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

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Link to this recall

<a href="https://govinfonow.com/recall/65095-raystation-software-recalled-treatment-data-import-errors">RayStation Software Recalled: Treatment Data Import Errors (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-2426-2020 (May 26, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2426-2020 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.