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Use caution Medical device recall · FDA · Published June 29, 2018

RaySearch RayStation Software Versions 4.5-8A: Risk of Overdose in Radiation Therapy

RaySearch recalls specific versions of RayStation software for radiation therapy planning due to potential overdose risk if beam models are asymmetric. Users must verify their version and contact RaySearch for updates.

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

🇺🇸 FDA recall #Z-2497-2018Medical deviceRaySearch ›
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Recalling firmRAYSEARCH LABORATORIES ABSveavagen 9 · Stockholm, Sweden
✎ GovInfoNow plain-language explainer

RaySearch recalls several versions of its RayStation software for radiation therapy treatment planning. If the software incorrectly calculates dose distributions when the collimator rotates, it could lead to overdosing patients during treatment. This is serious but requires user awareness to prevent incorrect dose calculations. Read more at govinfonow.com/recall/70693-raysearch-raystation-software-versions-4-5-8a-risk-of-overdose.

Source Summary by GovInfoNow · govinfonow.com/recall/70693-raysearch-raystation-software-versions-4-5-8a-risk-of-overdose · Updated August 20, 2026 · FDA enforcement record: FDA #Z-2497-2018

Cite this page

“RaySearch RayStation Software Versions 4.5-8A: Risk of Overdose in Radiation Therapy.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/70693-raysearch-raystation-software-versions-4-5-8a-risk-of-overdose. Based on FDA recall #Z-2497-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2497-2018%22&limit=1).

The FDA announced on June 29, 2018, that RaySearch Laboratories AB is recalling certain versions of its RayStation stand-alone software treatment planning system. The agency stated the devices pose a hazard of potentially significant overdosage at delivery due to incorrect dose calculations. Owners should be aware of the issue to avoid incorrect dose calculations during treatment planning.

How to tell if you have it

  • Brand: RaySearch
  • Product: RayStation stand-alone software treatment planning system
  • Versions: RayStation 4.5, RayStation 4.7, RayStation 4.9 (RayPlan 1), RayStation 5, RayStation 6 (RayPlan 2), RayStation 7 (RayPlan 7) and RayStation 8A (RayPlan 8A)
  • Software Versions: 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, 5.0.2.3, 6.0.0.24, 6.1.0.26, 6.1.1.2, 6.2.0.7, 7.0.0.19, 8.0.0.61
  • Quantity: 746 units
  • Distribution: US Nationwide Distribution to accounts in 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, and WI

The hazard

According to the FDA, if the beam model has a highly asymmetric primary source, it is not correctly taken into account in the calculation of DMLC fields when the collimator is rotated. This could lead to potentially significant overdosage at delivery.

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 Reflexion X1 Radiotherapy System Software Defect May Cause Incorrect Dose Delivery (Feb. 9, 2026), Elekta Leksell GammaPlan 11.1 Software Recall: Risk of Incorrect Patient Irradiation (Dec. 12, 2025) and Elekta Leksell GammaPlan software version 11.3/11.4 recall: Risk of incorrect patient irradiation (Dec. 12, 2025).

How to tell if you have this one

Check if your RayStation software version is listed in the specific versions mentioned: 4.5, 4.7, 4.9 (RayPlan 1), 5, 6 (RayPlan 2), 7 (RayPlan 7), or 8A (RayPlan 8A). The software is used by radiation therapy professionals for treatment planning.

  • Brand
    RaySearch
  • 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's version number in the system settings or documentation.

  2. Contact RaySearch

    Reach out to RaySearch directly for guidance on whether your version requires correction or updates.

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 to accounts in 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, 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, 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 2 years after the firm started it.

1. Firm started the recall: Jun 29, 201812. FDA classified it Class II: Jul 19, 201823. Published in FDA’s Enforcement Report: Jul 25, 201834. FDA terminated the recall: Jul 16, 2020420182020
  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-2497-2018 (June 29, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2497-2018 to see it in context.
  • Plain-language summary written by qwen3:4b on August 20, 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