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Lower risk Medical device recall · FDA · Published April 7, 2021

RayStation Software: Incorrect Total Dose Display in Radiation Therapy Planning

RaySearch Laboratories recalls RayStation software versions 8.0.0.6 to 10.1.0.613 for potential incorrect total dose displays during radiation therapy treatment planning. Users should verify dose tracking settings to avoid treatment errors.

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

🇺🇸 FDA recall #Z-1598-2021Medical deviceRaySearch Laboratories ›
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Recalling firmRAYSEARCH LABORATORIES ABSveavagen 9 · Stockholm, Sweden
✎ GovInfoNow plain-language explainer

RaySearch Laboratories is recalling specific versions of their RayStation radiation therapy software due to a potential error in the 'Total dose' display when using multiple treatment plans. This could lead to incorrect dose calculations if not addressed, though the issue only affects certain software settings and users. Read more at govinfonow.com/recall/62835-raystation-software-incorrect-total-dose-display-in-radiation-therapy-planning.

Source Summary by GovInfoNow · govinfonow.com/recall/62835-raystation-software-incorrect-total-dose-display-in-radiation-therapy-planning · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1598-2021

Cite this page

“RayStation Software: Incorrect Total Dose Display in Radiation Therapy Planning.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62835-raystation-software-incorrect-total-dose-display-in-radiation-therapy-planning. Based on FDA recall #Z-1598-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1598-2021%22&limit=1).

The FDA announced on April 7, 2021, that RaySearch Laboratories AB is recalling RayStation standalone software radiation therapy treatment planning systems due to potential incorrect total dose displays. The agency issued recall number Z-1598-2021 for the voluntary Class II action.

How to tell if you have it

  • Brand: RaySearch Laboratories
  • Product: RayStation standalone software radiation therapy treatment planning system
  • Model Numbers: 8A, 8B, 9A, 9B, 10A, 10B
  • Software versions: 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
  • Distribution: Domestic: TN

The hazard

According to the FDA, when using more than one plan in a treatment course, the Total dose display in Dose tracking may be incorrect for RayTreat users. There may be a mismatch between the fractions selected in the Treatment course list and those included in the dose summation.

Context

GovInfoNow's records show RaySearch Laboratories AB has 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), Boston Scientific TheraSphere 360 Y-90 Software Anomaly Recall (June 19, 2026), 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 for software versions listed: 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, or 10.1.0.613. The issue only impacts users with the 'Total dose' option in Dose tracking.

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

What to do — step by step

  1. Verify Software Version

    Check your RayStation software version to see if it matches the listed versions (8.0.0.6 through 10.1.0.613).

Where it went and when

Where it was distributed

Distributed in Tennessee.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: not listedWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: not listedMNIllinois: not listedILWisconsin: not listedWIMichigan: not listedMINew York: not listedNYRhode Island: not listedRIMassachusetts: not listedMAOregon: not listedORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: not listedIAIndiana: not listedINOhio: not listedOHPennsylvania: not listedPANew Jersey: not listedNJConnecticut: not listedCTCalifornia: not listedCAUtah: not listedUTColorado: not listedCONebraska: not listedNEMissouri: not listedMOKentucky: not listedKYWest Virginia: not listedWVVirginia: not listedVAMaryland: not listedMDDelaware: not listedDEArizona: not listedAZNew Mexico: not listedNMKansas: not listedKSArkansas: not listedARTennessee: yesTNNorth Carolina: not listedNCSouth Carolina: not listedSCDistrict of Columbia: not listedDCOklahoma: not listedOKLouisiana: not listedLAMississippi: not listedMSAlabama: not listedALGeorgia: not listedGAHawaii: not listedHITexas: not listedTXFlorida: not listedFL

FDA distribution: “Domestic: TN” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Tennessee.

Recall timeline

FDA terminated this recall 2.2 years after the firm started it.

1. Firm started the recall: Apr 7, 202112. FDA classified it Class II: May 14, 202123. Published in FDA’s Enforcement Report: May 26, 202134. FDA terminated the recall: Jun 2, 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.

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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-1598-2021 (April 7, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1598-2021 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