Use caution Medical device recall · FDA · Published September 9, 2021

RaySearch RayStation software versions 6-11A recall: Unexpected jaw movement during

RaySearch Laboratories recalls RayStation software versions 6 through 11A with specific build numbers due to potential unexpected jaw position changes during radiation treatment planning if dose grid or target ROI is modified after optimization.

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

🇺🇸 FDA recall #Z-0848-2022Medical device RaySearch Laboratories ›

Use caution until it’s fixed

If the dynamic jaw mode is used and an optimization is continued after changing the dose grid or modifying the target ROI, the positions of the jaws may change unexpectedly for some control points. User must be aware to avoid unnecessary jaw openings during treatment planning

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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 software (6 through 11A) because changing the dose grid or target area during treatment planning after using dynamic jaw mode could cause unexpected jaw movements. This could lead to unintended radiation exposure if not corrected. Read more at govinfonow.com/recall/61817-raysearch-raystation-software-versions-6-11a-recall-unexpected-jaw-movement.

Source Summary by GovInfoNow · govinfonow.com/recall/61817-raysearch-raystation-software-versions-6-11a-recall-unexpected-jaw-movement · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0848-2022

Cite this page

“RaySearch RayStation software versions 6-11A recall: Unexpected jaw movement during.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61817-raysearch-raystation-software-versions-6-11a-recall-unexpected-jaw-movement. Based on FDA recall #Z-0848-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0848-2022%22&limit=1).

The FDA announced on Sept. 9, 2021, that RaySearch Laboratories AB is recalling TomoHelical and TomoDirect plans in RayStation software versions 6 through 11A due to potential unexpected jaw position changes during treatment planning. The agency issued recall number Z-0848-2022 for the voluntary Class II action affecting 51 licenses distributed nationwide.

How to tell if you have it

Brand: RaySearch Laboratories
Product: TomoHelical and TomoDirect plans in RayStation 6, 7, 8A, 8B, 9A, 9B, 10A, 10B and 11A
Build Numbers: 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, 10.1.0.613, 11.0.0.951 or 11.0.1.29
Distribution: US Nationwide in AL, CA, FL, GA, IA, IL, MO, MS, NC, OK, OR, SC, TN, WA, WI
Units affected: 51 licenses

The hazard

According to the FDA, if the dynamic jaw mode is used and an optimization is continued after changing the dose grid or modifying the target ROI, the positions of the jaws may change unexpectedly for some control points. The record states that users must be aware to avoid unnecessary jaw openings during treatment planning.

Context

GovInfoNow's records show RaySearch Laboratories AB has issued 36 other recalls since July 17, 2017. Recent brand recalls include a May 20, 2026 recall for RayCare 2:024A SP1 Oncology Software due to data loss risk and an Aug. 8, 2025 recall for RayStation Software regarding unique DICOM UIDs causing data conflicts. Other recent recalls of similar products include the Dec. 12, 2025 Elekta Leksell GammaPlan 11.1 Software Recall for risk of incorrect patient irradiation and the Feb. 6, 2026 Hitachi Proton Beam Therapy System Recall for positioning software anomaly risk.

How to tell if you have this one

Check if you have RayStation software versions 6 through 11A with build numbers including 6.1.1.2, 6.2.0.7, or other specific build numbers listed in the recall. The software was sold with the UDI-DI codes provided in the recall notice.

Brand
RaySearch Laboratories
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Software Version
Verify your RayStation software version and build number against the list of affected versions provided in the recall notice.
Review Treatment Planning Process
Ensure that you do not change the dose grid or modify the target radiation area after completing an optimization process in dynamic jaw mode.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 15 states.

FDA distribution: “US Nationwide distribution in the states of AL, CA, FL, GA, IA, IL, MO, MS, NC, OK, OR, SC, TN, WA, WI.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, California, Florida, Georgia, Illinois, Iowa, Mississippi, Missouri, North Carolina, Oklahoma, Oregon, South Carolina, Tennessee, Washington, Wisconsin.

Recall timeline

FDA terminated this recall 2.6 years after the firm started it.

Sep 9, 2021Firm started the recall
Mar 31, 2022FDA classified it Class II
Apr 6, 2022Published in FDA’s Enforcement Report
Apr 16, 2024FDA 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/61817-raysearch-raystation-software-versions-6-11a-recall-unexpected-jaw-movement">RaySearch RayStation software versions 6-11A recall: Unexpected jaw movement during (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-0848-2022 (September 9, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0848-2022 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.