Lower risk Medical device recall · FDA · Published February 22, 2021

RaySearch RayStation software recall: Dose labeling error in beam merging

RaySearch recalls specific versions of RayStation and RayPlan software due to potential dose labeling errors when merging clinical beams. Affected versions include 4.5 to 10.1 with certain service packs. No immediate action is required but users should check their software version.

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

🇺🇸 FDA recall #Z-1597-2021Medical device RaySearch ›

Lower-risk recall

For some LINAC types, merging clinical beams with beams of approximate dose may lead to the approximate dose erroneously labeled as clinical dose. Merge beams can be used manually, in scripting, or as part of the Automated breast planning feature. In some cases, when merging two beams where the first beam has clinical dose and the second beam has approximate dose, the dose of the resulting beam will be labeled as Clinical , although dose for some of the beam segments is still calculated with the SVD dose engine and it should be labeled Approximate: Mixed dose . The difference between approximate and final Clinical dose is in most cases small, but there can be body sites such as lung where the difference can be significant.

Take action

Contact the company

Recalling firmRAYSEARCH LABORATORIES ABSveavagen 9 · Stockholm, Sweden

✎ GovInfoNow plain-language explainer

RaySearch Laboratories is recalling specific versions of their RayStation and RayPlan software due to a potential error in dose labeling when merging certain radiation therapy beams. This could lead to incorrect dose calculations for some patients, particularly in areas like the lungs where the difference might be significant. The recall does not require immediate action but users should verify their software version. Read more at govinfonow.com/recall/63254-raysearch-raystation-software-recall-dose-labeling-error-in-beam-merging.

Source Summary by GovInfoNow · govinfonow.com/recall/63254-raysearch-raystation-software-recall-dose-labeling-error-in-beam-merging · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1597-2021

Cite this page

“RaySearch RayStation software recall: Dose labeling error in beam merging.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63254-raysearch-raystation-software-recall-dose-labeling-error-in-beam-merging. Based on FDA recall #Z-1597-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1597-2021%22&limit=1).

The FDA announced on Feb. 22, 2021, that RaySearch Laboratories AB is recalling RayStation and RayPlan software versions due to a hazard where approximate dose may be erroneously labeled as clinical dose. The agency said the recall affects 116 units distributed nationwide.

How to tell if you have it

RayStation 4.5, 4.7, 4.9, 5, 6, 7, 8A, 8B, 9A, 9B, 10A, 10B
RayPlan 1, 2, 7, 8A, 8B, 9A, 10A, 10B
Build numbers: 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, 10.0.1.52, or 10.1.0.613
RayStation 4.0 (4.0.0.14) to RayStation 5 Service Pack 2 (5.0.2.35)
RayStation 5 Service Pack 3 (5.0.3.17) UDI 07350002010020
RayStation 6/RayPlan 2 (6.0.0.24) UDI 07350002010013
RayStation 6/RayPlan 2 Service Pack 1 (6.1.1.2) UDI 07350002010082
RayStation 6/RayPlan 2 Service Pack 2 (6.2.0.7) UDI 07350002010075
RayStation 6/RayPlan 2 Service Pack 3 (6.3.0.6) UDI 07350002010242
RayStation/RayPlan 7 (7.0.0.19) UDI 07350002010068
RayStation/RayPlan 8A (8.0.0.61) UDI 07350002010112
RayStation/RayPlan 8A Service Pack 1 (8.0.1.10) UDI 07350002010136
RayStation/RayPlan 8B (8.1.0.47) UDI 07350002010129
RayStation/RayPlan 8B Service Pack 1 (8.1.1.8) UDI 07350002010204
RayStation/RayPlan 8B Service Pack 2 (8.1.2.5) UDI 07350002010235
RayStation/RayPlan 9A (9.0.0.113) UDI 07350002010174
RayStation/RayPlan 9B (9.1.0.933) UDI 07350002010266
RayStation/RayPlan 9B Service Pack 1 (9.2.0.483) UDI 07350002010297
RayStation/RayPlan 10A (10.0.0.1154) UDI 07350002010303
RayStation/RayPlan 10A Service Pack 1 (10.0.1.52) UDI 07350002010365
RayStation/RayPlan 10B (10.1.0.613) UDI 07350002010310

The hazard

The FDA said that for some LINAC types, merging clinical beams with beams of approximate dose may lead to the approximate dose erroneously labeled as clinical dose. The record notes that while the difference between approximate and final clinical dose is in most cases small, it can be significant for body sites such as lung.

Context

GovInfoNow's records show RaySearch Laboratories AB has had 36 other recalls on record since July 17, 2017. Other recent recalls of similar products include RayCare 2:024A SP4 Oncology Software Data Loss Risk (May 20, 2026), RayStation Software Version 17.0.0-17.0.1 Radiation Dose Calculation Risk (Nov. 28, 2025), and RayStation Software Version 7.0.0.19 and 8.0.0.61 Recall: Unique DICOM IDs Risk (Aug. 8, 2025). Other recent recalls of similar products include Elekta Leksell GammaPlan 11.1 Software Recall: Risk of Incorrect Patient Irradiation (Dec. 12, 2025), Elekta Leksell GammaPlan software version 11.3/11.4 recall: Risk of incorrect patient irradiation (Dec. 12, 2025), and Hitachi Proton Beam Therapy System Recall: Positioning Software Anomaly Risk (Feb. 6, 2026).

How to tell if you have this one

Check if your software version matches the listed versions (4.5 to 10.1) with specific service packs. The software includes build numbers like 4.5.1.14 or UDI codes such as 07350002010020.

Brand
RaySearch
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Software Version
Verify your RayStation or RayPlan version against the list of affected versions provided in the recall notice.

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 2.2 years after the firm started it.

Feb 22, 2021Firm started the recall
May 14, 2021FDA classified it Class II
May 26, 2021Published in FDA’s Enforcement Report
May 1, 2023FDA terminated the recall

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/63254-raysearch-raystation-software-recall-dose-labeling-error-in-beam-merging">RaySearch RayStation software recall: Dose labeling error in beam merging (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-1597-2021 (February 22, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1597-2021 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.