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Use caution Medical device recall · FDA · Published November 18, 2019

RaySearch RayStation Software Recalled: Editing Arc Beam May Cause Invalid Dose

RaySearch recalls specific versions of RayStation treatment planning software due to a bug that may set beam dose to default values, requiring recalibration before treatment approval.

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

🇺🇸 FDA recall #Z-0736-2020Medical deviceRaySearch ›
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Recalling firmRAYSEARCH LABORATORIES ABSveavagen 9 · Stockholm, Sweden
✎ GovInfoNow plain-language explainer

RaySearch Laboratories is recalling specific versions of their RayStation software treatment planning system. A bug can cause the software to reset dose calculations to default values, meaning treatments may be unsafe if not corrected before approval. Read more at govinfonow.com/recall/66504-raysearch-raystation-software-recalled-editing-arc-beam-may-cause-invalid.

Source Summary by GovInfoNow · govinfonow.com/recall/66504-raysearch-raystation-software-recalled-editing-arc-beam-may-cause-invalid · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0736-2020

Cite this page

“RaySearch RayStation Software Recalled: Editing Arc Beam May Cause Invalid Dose.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/66504-raysearch-raystation-software-recalled-editing-arc-beam-may-cause-invalid. Based on FDA recall #Z-0736-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0736-2020%22&limit=1).

The FDA announced on 2019-11-18 that RaySearch Laboratories AB is recalling RayStation stand-alone software treatment planning systems, model numbers 4.0 through 6.3, due to a hazard where editing a static arc beam may unexpectedly reset the MU to 200, invalidating the dose. This recall affects 956 devices distributed nationwide.

How to tell if you have it

  • Brand: RaySearch
  • Product: RayStation stand-alone software treatment planning system
  • Model Numbers: 4.0, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1, 6.2, 6.3
  • Software Versions: 4.0.0.14, 4.0.1.4, 4.0.2.9, 4.0.3.4, 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
  • Quantity: 956 Devices/Licences
  • Distribution: US Nationwide in AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, ID, IL, LA, MA, MD, ME, MI, MO, MS, MT, NC, NJ, NY, OH, OK, OR, PA, RI, TN, TX, UT, VA, VT, WA, and WI

The hazard

According to the FDA, editing a static arc beam may unexpectedly set the MU of the beam to its initial default value of 200 MU. If this bug is triggered, the dose is invalidated and needs to be recalculated before the plan can be approved or exported.

Context

GovInfoNow's records show RaySearch Laboratories AB has had 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 Elekta Leksell GammaPlan 11.1 Software Recall: Risk of Incorrect Patient Irradiation (2025-12-12), Boston Scientific TheraSphere 360 Y-90 Software Anomaly Recall (2026-06-19), and Elekta Leksell Vantage Arc System Recall: Risk of shifting coordinates during procedures (2026-03-19).

How to tell if you have this one

Check your RayStation software version numbers listed in the recall notice: 4.0, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1, 6.2, 6.3, 7.0, 8.0, 8.1, or 9.0. The software is used for radiation therapy treatment planning by trained medical staff.

  • 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 matches the recalled versions listed in the notice.

  2. Recalculate Dose

    If you edited a static arc beam, recalculate the dose before approving or exporting the treatment plan.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 35 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: 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: 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 the 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, NY, OH, OK, OR, PA, RI, TN, TX, UT, VA, VT, WA, and 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, 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 12 months after the firm started it.

1. Firm started the recall: Nov 18, 201912. FDA classified it Class II: Dec 23, 201923. Published in FDA’s Enforcement Report: Jan 1, 202034. FDA terminated the recall: Nov 10, 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.

✎ GovInfoNow

Questions people ask

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

What versions of RayStation are affected?

Software versions 4.0 through 9.0, including specific build numbers like 4.0.0.14, 4.5.0.19, and 9.0.0.113.

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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-0736-2020 (November 18, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0736-2020 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.
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