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Use caution Medical device recall · FDA · Published January 26, 2018

RayStation Software Recalls: Incorrect Treatment Volume Risk

RaySearch Laboratories recalls RayStation 4.9-7 software versions with incorrect treatment volume delivery risk. Affected units may require software update to prevent patient safety issues.

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

🇺🇸 FDA recall #Z-1275-2018Medical deviceRaySearch Laboratories ›
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Recalling firmRAYSEARCH LABORATORIES ABSveavaegen 9 · Stockholm, Sweden
✎ GovInfoNow plain-language explainer

RaySearch Laboratories is recalling specific software versions of their RayStation 4.9 to 7 systems. These versions can deliver incorrect treatment volumes to patients, potentially causing harm during radiation therapy. Read more at govinfonow.com/recall/72093-raystation-software-recalls-incorrect-treatment-volume-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/72093-raystation-software-recalls-incorrect-treatment-volume-risk · Updated August 31, 2026 · FDA enforcement record: FDA #Z-1275-2018

Cite this page

“RayStation Software Recalls: Incorrect Treatment Volume Risk.” GovInfoNow, updated August 31, 2026. https://govinfonow.com/recall/72093-raystation-software-recalls-incorrect-treatment-volume-risk. Based on FDA recall #Z-1275-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1275-2018%22&limit=1).

RaySearch Laboratories AB voluntarily recalled Ray Station software builds 4.9.0.42 through 7.0.0.19 due to a Center Beam in Field software issue that can result in incorrect treatment volume delivered to patients, according to the FDA on Jan. 26, 2018.

How to tell if you have it

  • Brand: RaySearch Laboratories
  • Products: Ray Station 4.9, Ray Station 5, Ray Station 6 and Ray Station 7
  • Software build numbers: 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 or 7.0.0.19
  • UDI: 0735000201006820171130
  • Units affected: 2484

The hazard

The recall involves a software issue with Center Beam in Field functionality that can result in incorrect treatment volume delivered to patients, according to the FDA.

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 Elekta Leksell GammaPlan 11.1 Software Recall: Risk of Incorrect Patient Irradiation (Dec. 12, 2025), Elekta MOSAIQ Oncology System Software Recall: Treatment Plan Loading Risk (May 21, 2026) and Hitachi Proton Beam Therapy System Recall: Positioning Software Anomaly Risk (Feb. 6, 2026).

How to tell if you have this one

Check if your RayStation software version matches any of the listed build numbers: 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, or 7.0.0.19. The recall includes specific software builds for RayStation 4.9 through 7 systems.

  • 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 software version by checking the build number in the system settings.

  2. Update Software

    Contact RaySearch Laboratories to obtain the latest software update that fixes the Center Beam in Field issue.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

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

Distributed nationwide.

Recall timeline

FDA terminated this recall 2 years after the firm started it.

1. Firm started the recall: Jan 26, 201812. FDA classified it Class II: Mar 29, 201823. Published in FDA’s Enforcement Report: Apr 4, 201834. FDA terminated the recall: Jan 13, 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-1275-2018 (January 26, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1275-2018 to see it in context.
  • Plain-language summary written by qwen3:4b on August 31, 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