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Unrated Medical device recall · FDA · Published January 16, 2025

RayStation Software Version 11A Recalled Due to Density Uncertainty Errors

RaySearch Laboratories recalls RayStation software versions 11A and 11A Service Packs 1-3 with model numbers 1.0.0.951 and others due to density uncertainty errors in radiation therapy planning.

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

🇺🇸 FDA recall #Z-1189-2025Medical deviceRaySearch Laboratories ›
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Recalling firmRAYSEARCH LABORATORIES ABEugeniavagen 18c · Stockholm, Sweden
✎ GovInfoNow plain-language explainer

RaySearch Laboratories is recalling specific versions of their RayStation radiation therapy software because of inconsistencies in density calculations that could affect treatment accuracy. This recall affects medical professionals using the software for radiation therapy planning. Read more at govinfonow.com/recall/53064-raystation-software-version-11a-recalled-due-to-density-uncertainty-errors.

Source Summary by GovInfoNow · govinfonow.com/recall/53064-raystation-software-version-11a-recalled-due-to-density-uncertainty-errors · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1189-2025

Cite this page

“RayStation Software Version 11A Recalled Due to Density Uncertainty Errors.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/53064-raystation-software-version-11a-recalled-due-to-density-uncertainty-errors. Based on FDA recall #Z-1189-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1189-2025%22&limit=1).

The FDA announced on Jan. 16, 2025, that RaySearch Laboratories AB is recalling its RayStation radiation therapy treatment planning system due to potential inconsistencies in density uncertainty calculations for proton and light ion plans. The agency issued recall number Z-1189-2025 for the Class II device.

How to tell if you have it

  • Brand: RayStation
  • Model/Catalog Numbers: 1.0.0.951, 11.0.1.29, 11.0.3.116, 11.0.4.15
  • Software Revisions: RayStation 11A and 11A Service Pack 1, 2 and 3
  • Lot Codes (UDI): 0735000201038920210518, 0735000201043320210610, 0735000201044020210916, 0735000201063120220616
  • GTINs: 07350002010389, 07350002010433, 07350002010440, 07350002010631
  • Serial Numbers: 11.0.0.951, 11.0.1.29, 11.0.3.116, 11.0.4.15
  • Expiration Date: 2027-06-22
  • Units affected: 6

The hazard

The recall addresses an inconsistency in the use of Density uncertainty in RayStation functions Robust optimization, Robust evaluation and Compute perturbed dose for proton and light ion treatment plans when a HU-to-mass density CT calibration curve is used. This issue affects RayStation versions 4.5 to 2024B including some service packs.

Context

GovInfoNow's records show RaySearch Laboratories AB has issued 36 other recalls since July 17, 2017. Recent brand recalls include a May 20, 2026 recall for RayCare 2:024A SP1 Oncology Software regarding data loss risk and an Aug. 8, 2025 recall for RayStation versions 14.0.0.3338 and 15.0.0.430 concerning unique DICOM IDs. Other recent recalls of similar products include the Dec. 12, 2025 Elekta Leksell GammaPlan software recall for incorrect patient irradiation risk and the June 19, 2026 Boston Scientific TheraSphere 360 Y-90 Software Anomaly Recall.

How to tell if you have this one

Check for model numbers 1.0.0.951, 11.0.1.29, 11.0.3.116, or 11.0.4.15. The software versions include RayStation 11A and service packs 1-3 with specific lot codes and expiration dates.

  • Brand
    RaySearch Laboratories
  • Product
    Brand Name: RayStation
  • Category
    Medical device
FDA recall event · 11 products

All 11 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Ongoing
  • Distribution
    Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Belgium ENG, Canada, China, China APactron, Denmark, France, Germany, Hong Kong S.A.R. China, India, Italy, Japan, Korea, Netherlands, Norway, Poland, Singapore, Spain, SwitzerlandENG, Taiwan, Thailand, UK.
Recall numberProduct, codes & lotsQuantity
Z-1185-2025Brand Name: RayStation Intended as a Radiation Therapy Treatment Planning System. Model/Catalog Number: 7.0.0.19, 8.0.0.61, 8.0.1.10 Software Version: RayStation 7, 8A and 8A Service Pack 1; Lot Code: UDI: 0735000201006820171130, 0735000201011220180608 and 0735000201013620180928 GTIN: 07350002010068, 07350002010112 and 07350002010136 Serial Numbers: 7.0.0.19, 8.0.0.61 and 8.0.1.10 Software Revision: RayStation 7, 8A and 8A Service Pack 1 Expiration Date: 2023-10-040
Z-1186-2025Brand Name: RayStation -Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 8.1.0.47, 8.1.1.8, 8.1.2.5, 9.0.0.113 and 9.0.1.142 Software Version: RayStation 8B, 8B Service Pack 1 and 2, 9A and 9A Service Pack 1; Lot Code: UDI: 0735000201011220180608, 0735000201013620180928, 0735000201017420190612 and 0735000201048820220420 GTIN: 07350002010112, 07350002010136, 07350002010174 and 07350002010488 Serial Numbers: 8.0.0.61, 8.0.1.10, 9.0.0.113 and 9.0.1.142 Software Revisions: RayStation 8B, 8B Service Pack 1 and 2, 9A and 9A Service Pack 1 Expiration Date: 2027-12-151
Z-1187-2025Brand Name: RayStation -Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 9.1.0.933, 9.2.0.483, 10.0.0.1154, 10.0.1.52 and 10.0.2.10 Software Version: RayStation 9B, 9B Service Pack 1, 10A, 10A Service Pack 1 and 2; Lot Code: UDI: 0735000201026620191220, 0735000201029720200310, 0735000201030320200526, 0735000201036520200526 and 0735000201065520220608 GTIN: 07350002010266 and 07350002010297, 07350002010303, 07350002010365 and 07350002010655 Serial Numbers: 9.1.0.933, 9.2.0.483, 10.0.0.1154, 10.0.1.52 and 10.0.2.10 Software Revisions: RayStation 9B, 9B Service Pack 1, 10A, 10A Service Pack 1 and 2 Expiration Date: 2025-06-161
Z-1188-2025Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 10.1.0.613 and 10.1.1.54 Software Version: RayStation 10B and 10B Service Pack 1; Lot Code: UDI: 0735000201031020201216 and 0735000201047120220128 GTIN: 07350002010310 and 07350002010471 Serial Numbers: 10.1.0.613 and 10.1.1.54 Software Revisions: RayStation 10B and 10B Service Pack 1 Expiration Date: 2027-02-010
Z-1189-2025Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 1.0.0.951, 11.0.1.29, 11.0.3.116 and 11.0.4.15 Software Revisions: RayStation 11A and 11A Service Pack 1, 2 and 3; Lot Code: UDI: 0735000201038920210518, 0735000201043320210610, 0735000201044020210916 and 0735000201063120220616 GTIN: 07350002010389, 07350002010433, 07350002010440 and 07350002010631 Serial Numbers: 11.0.0.951, 11.0.1.29, 11.0.3.116 and 11.0.4.15 Software Revisions: RayStation 11A and 11A Service Pack 1, 2 and 3 Expiration Date: 2027-06-226
Z-1190-2025Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 12.0.0.932, 12.1.0.1221, 12.0.3.68, 12.0.4.12 and 12.3.0.119 Software Version: RayStation 11B and 11B Service Pack 1, 2, 3 and Service Pack Toshiba 1; Lot Code: UDI: 0735000201042620211208, 0735000201049520220312, 0735000201050120220422, 0735000201060020220620 and 0735000201057020221222 GTIN: 07350002010426, 07350002010495, 07350002010501, 07350002010600 and 07350002010570 Serial Numbers: 12.0.0.932, 12.1.0.1221, 12.0.3.68, 12.0.4.12 and 12.3.0.119 Software Revisions: RayStation 11B and 11B Service Pack 1, 2, 3 and Service Pack Toshiba 1 Expiration Date: 2028-03-205
Z-1191-2025Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 13.0.0.1547, 13.1.0.144, 13.1.1.89 and 14.0.0.3338 Software Version: RayStation 12A, 12A Service Pack 1 and 2 and 2023B; Lot Code: UDI: 0735000201054920220616, 0735000201067920221007, 0735000201073020230913 and 0735000201055620230630 GTIN: 07350002010549, 07350002010679, 07350002010730 and 07350002010556 Serial Numbers: 13.0.0.1547, 13.1.0.144, 13.1.1.89 and 14.0.0.3338 Software Revisions: RayStation 12A, 12A Service Pack 1 and 2 and 2023B Expiration Date: 2028-07-0732
Z-1192-2025Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 6.1.1.2, 6.2.0.7, 6.3.0.6 Software Version: RayStation 6 Service Pack 1, 2 and 3; Lot Code: UDI: 0735000201008220170529, 0735000201007520170630 and 0735000201024220190923 GTIN: 07350002010082, 07350002010075 and 07350002010242 Serial Numbers: 6.1.1.2, 6.2.0.7 and 6.3.0.6 Software Revisions: RayStation 6 Service Pack 1, 2 and 3 Expiration Date: 2024-10-181
Z-1193-2025Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 6.0.0.24 Software Version: RayStation 6; Lot Code: UDI: 00735000201001320161214 GTIN: 07350002010013 Serial Numbers: 6.0.0.24 Software Revisions: RayStation 6 Expiration Date: 2021-12-220
Z-1194-2025Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 5.0.2.35 and 5.0.3.17 Software Version: RayStation 5 Service Pack 2 and 3; Lot Code: UDI: 0735000201002020170502 GTIN: 07350002010020 Serial Numbers: 5.0.2.35 and 5.0.3.17 Software Revisions: RayStation 5 Service Pack 2 and 3 Expiration Date: 2028-12-210
Z-1195-2025Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 4.5.1.14, 4.7.2.5, 4.7.3.13, 4.7.4.4, 4.7.5.4 and 4.7.6.7 Software Version: RayStation 4.5.1, 4.7.2, 4.7.3, 4.7.4, 4.7.5 and 4.7.6; Lot Code: Serial Numbers: 4.5.1.14, 4.7.2.5, 4.7.3.13, 4.7.4.4, 4.7.5.4 and 4.7.6.7 Software Revisions: RayStation 4.5.1, 4.7.2, 4.7.3, 4.7.4, 4.7.5 and 4.7.6 Expiration Date: 2025-03-170
Based on the official FDA remedy

What to do — step by step

  1. Check Software Version

    Verify your RayStation version by checking the software revision and model numbers listed in the recall notice.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

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: “Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Belgium ENG, Canada, China, China APactron, Denmark, France, Germany, Hong Kong S.A.R. China, India, Italy, Japan, Korea, Netherlands, Norway, Poland,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA published this recall 41 days after the firm started it.

1. Firm started the recall: Jan 16, 202512. FDA classified it Class II: Feb 19, 202523. Published in FDA’s Enforcement Report: Feb 26, 202532025
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

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-1189-2025 (January 16, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1189-2025 to see it in context.
  • Plain-language summary written by qwen3:4b on August 18, 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