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Lower risk Medical device recall · FDA · Published December 19, 2019

RayStation Software Versions 4.0-9.0: Potential Incorrect Dose Calculations

RaySearch recalls software versions 4.0-9.0 for possible incorrect radiation dose calculations during cancer treatment planning. Users should verify their version and contact RaySearch for guidance.

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

🇺🇸 FDA recall #Z-0866-2020Medical deviceRaySearch ›
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Recalling firmRAYSEARCH LABORATORIES ABSveavagen 9 · Stockholm, Sweden
✎ GovInfoNow plain-language explainer

RaySearch Laboratories is recalling several versions of their RayStation software used in cancer treatment planning. These versions may generate incorrect radiation dose calculations if certain features are used, but no patient harm has been reported. Read more at govinfonow.com/recall/66253-raystation-software-versions-4-0-9-0-potential-incorrect-dose.

Source Summary by GovInfoNow · govinfonow.com/recall/66253-raystation-software-versions-4-0-9-0-potential-incorrect-dose · Updated August 10, 2026 · FDA enforcement record: FDA #Z-0866-2020

Cite this page

“RayStation Software Versions 4.0-9.0: Potential Incorrect Dose Calculations.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/66253-raystation-software-versions-4-0-9-0-potential-incorrect-dose. Based on FDA recall #Z-0866-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0866-2020%22&limit=1).

The FDA announced on 2019-12-19 that RaySearch Laboratories AB is recalling RayStation stand-alone software treatment planning systems due to potential incorrect dose calculations. The agency stated the recall was voluntary and initiated by the firm.

How to tell if you have it

  • Brand: RaySearch
  • Product: RayStation stand-alone software treatment planning system
  • Models: 4.0, 4.3, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1, 6.2, 6.3, 7.0, 8.0, 8.1, 9.0
  • Software Versions: 4.0.0.14, 4.0.1.4, 4.0.2.9, 4.0.3.4, 4.3.0.14, 4.5.0.19, 4.5.1.14, 4.5.2.7, 4.7.0.15, 4.7.1.10, 4.7.2.5, 4.7.3.13, 4.7.4.4, 4.7.5.4, 4.9.0.42, 5.0.0.37, 5.0.1.11, 5.0.2.35, 6.0.0.24, 6.1.0.26, 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
  • Units affected: 3114 Devices/Licenses

The hazard

The recall cites three issues: unintended ROI geometries in the Structure Definition module, an interoperability issue with Elekta regarding guard leaf settings, and SSD sometimes providing source-to-skin distance instead of source-to-surface distance. According to the record, these issues have not caused any patient mistreatment or other incidents to the best of the company's knowledge.

Context

GovInfoNow's records show RaySearch Laboratories AB has 36 other recalls on record since 2017-07-17. Other recent recalls of similar products include RayCare 2:024A SP1 Oncology Software Data Loss Risk (2026-05-20), RayStation 2024B Software Recall: Radiation Dose Calculation Errors (2025-11-28), and RayStation Software Version 8.1.0.47: Unique DICOM IDs Risk (2025-08-08). Other recent recalls of similar products include Boston Scientific TheraSphere 360 Y-90 Software Anomaly Recall (2026-06-19), Elekta Leksell GammaPlan software version 11.3/11.4 recall: Risk of incorrect patient irradiation (2025-12-12), and Elekta Leksell GammaPlan 11.1 Software Recall: Risk of Incorrect Patient Irradiation (2025-12-12).

How to tell if you have this one

Check your RayStation software version number. Affected versions include 4.0, 4.3, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1, 6.2, 6.3, 7.0, 8.0, 8.1, and 9.0 with specific build numbers listed in the recall.

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

What to do — step by step

  1. Check Software Version

    Verify your RayStation software version against the list of affected versions provided in the recall.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 36 states.

Alaska: nationwideAKMaine: 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: named in the noticeNVWyoming: 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: named in the noticeCONebraska: 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: nationwideNMKansas: nationwideKSArkansas: named in the noticeARTennessee: named in the noticeTNNorth Carolina: named in the noticeNCSouth Carolina: nationwideSCDistrict 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: “US Nationwide distribution in states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, ID, IL, LA, MA, MD, ME, MI, MO, MS, MT, NC, NJ, NV, NY, OH, OK, OR, PA, RI, TN, TX, UT, VA, VT, WA, WI” States read from FDA’s own wording; “not listed” means the notice does not name it.

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

Recall timeline

FDA terminated this recall 11 months after the firm started it.

1. Firm started the recall: Dec 19, 201912. FDA classified it Class II: Feb 4, 202023. Published in FDA’s Enforcement Report: Feb 5, 202034. FDA terminated the recall: Nov 24, 2020420192020
  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.

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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-0866-2020 (December 19, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0866-2020 to see it in context.
  • Plain-language summary written by qwen3:4b on August 10, 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