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Lower risk Medical device recall · FDA · Published April 21, 2021

RayStation Software Recalled: Misleading Dose Evaluation After Editing

RaySearch Laboratories recalls RayStation treatment planning software versions 6.0.0.24 to 10.1.0.613 due to potential misleading dose evaluations after clinical goal edits. Affected users should 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-1838-2021Medical deviceRaySearch Laboratories ›
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Contact the company

Recalling firmRAYSEARCH LABORATORIES ABSveavagen 9 · Stockholm, Sweden
✎ GovInfoNow plain-language explainer

RaySearch Laboratories is recalling several versions of their RayStation treatment planning software because editing clinical goals can lead to misleading dose evaluations. This could affect radiation therapy planning accuracy, but the recall does not require immediate discontinuation of use. Read more at govinfonow.com/recall/62747-raystation-software-recalled-misleading-dose-evaluation-after-editing.

Source Summary by GovInfoNow · govinfonow.com/recall/62747-raystation-software-recalled-misleading-dose-evaluation-after-editing · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1838-2021

Cite this page

“RayStation Software Recalled: Misleading Dose Evaluation After Editing.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62747-raystation-software-recalled-misleading-dose-evaluation-after-editing. Based on FDA recall #Z-1838-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1838-2021%22&limit=1).

The FDA announced on April 21, 2021, that RaySearch Laboratories AB is recalling RayStation Treatment Planning System software versions 6 through 10A. The agency cited potential misleading dose distribution evaluations and contouring issues as the hazard.

How to tell if you have it

  • Brand: RaySearch Laboratories
  • Product: RayStation (Treatment Planning System)
  • Model Numbers: 6.0.0.24, 6.1.1.2, 6.2.0.7, 6.3.0.6, 7.0.0.19, 8.0.0.6, 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
  • Software Versions: RayStation 6, 7, 8A, 8B, 9A, 9B, 10A, 10B, RayPlan 2 including some service packs

The hazard

GovInfoNow's records show the hazard involves misleading evaluation of clinical goals for voxelwise worst dose distributions after editing. It also describes an issue with contouring when the spacing between slices is less than 1 mm.

Context

RaySearch Laboratories AB has issued 36 other recalls since July 17, 2017. Recent brand recalls include RayCare 2:024A SP4 Oncology Software Data Loss Risk on May 20, 2026, and RayStation 10B Software May Cause Radiation Dose Errors on Nov. 28, 2025. Other recent recalls of similar products include Elekta Leksell GammaPlan 11.1 Software Recall on Dec. 12, 2025, and Boston Scientific TheraSphere 360 Y-90 Software Anomaly Recall on June 19, 2026.

How to tell if you have this one

Check if your RayStation software version is listed in the recall: 6.0.0.24, 6.1.1.2, 6.2.0.7, 6.3.0.6, 7.0.0.19, 8.0.0.6, 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, or 10.0.1.52.

  • Brand
    RaySearch Laboratories
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Software Version

    Identify your RayStation version by checking the software menu or documentation.

  2. Contact Support

    Reach out to RaySearch Laboratories for updates or alternative solutions.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 36 states.

Alaska: named in the noticeAKMaine: named in the noticeMEVermont: named in the noticeVTNew Hampshire: nationwideNHWashington: named in the noticeWAIdaho: named in the noticeIDMontana: named in the noticeMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: named in the noticeILWisconsin: named in the noticeWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: named in the noticeRIMassachusetts: named in the noticeMAOregon: named in the noticeORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: nationwideINOhio: named in the noticeOHPennsylvania: named in the noticePANew Jersey: named in the noticeNJConnecticut: named in the noticeCTCalifornia: named in the noticeCAUtah: named in the noticeUTColorado: nationwideCONebraska: nationwideNEMissouri: named in the noticeMOKentucky: nationwideKYWest Virginia: nationwideWVVirginia: named in the noticeVAMaryland: named in the noticeMDDelaware: named in the noticeDEArizona: named in the noticeAZNew Mexico: named in the noticeNMKansas: nationwideKSArkansas: nationwideARTennessee: named in the noticeTNNorth Carolina: named in the noticeNCSouth Carolina: named in the noticeSCDistrict of Columbia: named in the noticeDCOklahoma: named in the noticeOKLouisiana: named in the noticeLAMississippi: named in the noticeMSAlabama: named in the noticeALGeorgia: named in the noticeGAHawaii: named in the noticeHITexas: named in the noticeTXFlorida: named in the noticeFL

FDA distribution: “Worldwide distribution - US Nationwide distribution in the states of AK, AL, AZ, CA, CT, DC, DE, FL, GA, HI, ID, IL, LA, MA, MD, ME, MI, MO, MS, MT, NC, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI and the countries of…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Alaska, Arizona, California, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Louisiana, Maine, Maryland, Massachusetts, Michigan, Mississippi, Missouri, Montana, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Vermont, Virginia, Washington, Wisconsin.

Recall timeline

FDA terminated this recall 2.3 years after the firm started it.

1. Firm started the recall: Apr 21, 202112. FDA classified it Class II: Jun 9, 202123. Published in FDA’s Enforcement Report: Jun 16, 202134. FDA terminated the recall: Jul 27, 2023420212023
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

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

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Is this recall dangerous for patients?

The recall addresses potential inaccuracies in dose evaluation, but it does not pose an immediate risk to patients. Users should follow the recommended steps to ensure treatment accuracy.

Which versions are affected?

Versions from 6.0.0.24 to 10.1.0.613, including RayPlan 2 and some service packs, are affected.

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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-1838-2021 (April 21, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1838-2021 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA