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Lower risk Medical device recall · FDA · Published November 28, 2025

RayStation Software Version 17.0.0-17.0.1: Radiation Dose Calculation Risk

RayStation v2025 and v2025 SP1 software versions 17.0.0 and 17.0.1 may cause radiation dose calculations to fail for certain treatment areas. Affected users should contact RaySearch Laboratories for updates.

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

🇺🇸 FDA recall #Z-1110-2026Medical deviceRayStation ›
Take action

Contact the company

Recalling firmRAYSEARCH LABORATORIES ABEugeniavagen 18c · Stockholm, Sweden
✎ GovInfoNow plain-language explainer

RaySearch Laboratories is recalling specific versions of their RayStation radiation therapy software. The software may incorrectly calculate radiation doses for certain treatment areas, potentially leading to unsafe radiation exposure during cancer treatment. Read more at govinfonow.com/recall/50572-raystation-software-version-17-0-0-17-0-1-radiation.

Source Summary by GovInfoNow · govinfonow.com/recall/50572-raystation-software-version-17-0-0-17-0-1-radiation · Updated August 17, 2026 · FDA enforcement record: FDA #Z-1110-2026

Cite this page

“RayStation Software Version 17.0.0-17.0.1: Radiation Dose Calculation Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/50572-raystation-software-version-17-0-0-17-0-1-radiation. Based on FDA recall #Z-1110-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1110-2026%22&limit=1).

The FDA announced on Nov. 28, 2025, that RAYSEARCH LABORATORIES AB is voluntarily recalling RayStation/RayPlan software versions 17.0.0 and 17.0.1 due to a potential failure to invalidate calculated radiation dose for certain Regions of Interest.

How to tell if you have it

  • Brand: RayStation
  • Product Name: RayStation/RayPlan
  • Model/Catalog Number: 17.0.0, 17.0.1
  • Software Version: RayStation v2025, RayStation v2025 SP1
  • Lot Code/UDI: 0735000201082220250423, 0735000201094520250702
  • GTIN: 07350002010822, 07350002010945
  • Serial Numbers: 17.0.0.1270, 17.0.1.113

The hazard

According to the FDA, the hazard involves the invalidation of calculated radiation dose not working as intended for certain Regions of Interest (ROIs) that have no contours and either have a material override defined or are of type Bolus, Fixation, or Support. In these cases, adding geometry to the ROI, subsequently modifying geometry, or removing the material override does not invalidate dose as intended.

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 RayCare 2:024A SP1 Oncology Software Data Loss Risk (May 20, 2026), RayStation Software Version 12.0.0.932: Unique DICOM IDs Risk (Aug. 8, 2025), and RayStation 6.0.0.24 Software Recall: Density Uncertainty Risk in Radiation Therapy (Jan. 16, 2025). Other recent recalls of similar products include Elekta Leksell GammaPlan software version 11.3/11.4 recall: Risk of incorrect patient irradiation and Elekta Leksell GammaPlan 11.1 Software Recall: Risk of Incorrect Patient Irradiation (both Dec. 12, 2025), as well as Boston Scientific TheraSphere 360 Y-90 Software Anomaly Recall (June 19, 2026).

How to tell if you have this one

Check if your RayStation software version is 17.0.0 or 17.0.1. The software is sold as RayStation v2025 or v2025 SP1 with expiration date 2030-10-22.

  • Brand
    RayStation
  • Product
    Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 17.0.0, 17.0.1 Software Version
  • Category
    Medical device
FDA recall event · 9 products

All 9 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
    Refer to the attached documents: Distribution list 167168 US - updated, Distribution list 167168 OUS
Recall numberProduct, codes & lotsQuantity
Z-1102-2026RayStation/RayPlan. Model/Catalog Number: 10.1. Software Version: RayStation/RayPlan 10B. Radiation Therapy Treatment Planning System; UDI: 0735000201031020201216. GTIN: 07350002010310. Serial Numbers: 10.1.0.613. Software Revision: RayStation 10B. Expiration Date: 2027-02-01.0
Z-1103-2026RayStation/RayPlan. Model/Catalog Numbers: 11.0.0, 11.0.1, 11.0.3, 11.0.4. Software Version: RayStation 11A, RayStation 11A SP1, RayStation 11A SP2, RayStation 11A SP3. Radiation Therapy Treatment Planning System; Lot Code: UDI: 0735000201038920210518, 0735000201043320210610, 0735000201044020210916, 35000201063120220616. GTIN: 07350002010389, 07350002010433, 07350002010440, 07350002010631. Serial Numbers: 11.0.0.951, 11.0.1.29, 11.0.3.116, 11.0.4.15. Software Revision: RayStation 11A, 11A SP1, 11A SP2, 11A SP3. Expiration Date: 2027-06-22.10 units
Z-1104-2026RayStation/RayPlan. Model/Catalog Numbers: 12.0.0, 12.1.0, 12.0.3, 12.0.4, 12.3.0. Software Version: RayStation 11B, RayStation 11B SP1, RayStation 11B SP2, RayStation 11B SP3, RayStation 11B SPT1. Radiation Therapy Treatment Planning System; 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, 12.3.0.119. Software Revisions: RayStation 11B, 11B SP1, 11B SP2, 11B SP3, 11B SPT1. Expiration Date: 2028-03-20.22 units
Z-1105-2026Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 13.0.0.1547, 13.1.0.144, 13.1.1.89 Software Version: RayStation 12A, RayStation 12A SP1, RayStation 12A SP2 Product Description: Radiation Therapy Treatment Planning System Component: No; Lot Code: UDI: 0735000201054920220616, 0735000201067920221007, 0735000201073020230913 GTIN: 07350002010549, 07350002010679, 07350002010730 Serial Numbers: 13.0.0.1547, 13.1.0.144, 13.1.1.89 Software Revisions: RayStation 12A, 12A SP 1, 12A SP2 Expiration Date: 2028-07-078
Z-1106-2026Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 14.0.0, 15.0.0, 15.1.3 Software Version: RayStation 2023B, RayStation 2024A, RayStation 2024A SP3 Product Description: Radiation Therapy Treatment Planning System Component: No; Lot Code: UDI: 0735000201055620230630, 0735000201072320231213, 0735000201088420250129 GTIN: 07350002010556, 07350002010723, 07350002010884 Serial Numbers: 14.0.0.3338, 15.0.0.430, 15.1.3.10 Software Revisions: RayStation 2023B, RayStation 2024A, RayStation 2024A SP3 Expiration Date: 2030-02-21119
Z-1107-2026Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 10.1.1 Software Version: RayStation 10B SP1 Product Description: Radiation Therapy Treatment Planning System Component: No; Lot Code: UDI: 0735000201047120220131 GTIN: 07350002010471 Serial Numbers: 10.1.1.54 Software Revision: RayStation 10B SP1 Expiration Date: 2027-02-010
Z-1108-2026Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 15.2.0, 15.1.3 Software Version: RayStation 2024A SP1, RayStation 2024A SP2 Product Description: Radiation Therapy Treatment Planning System Component: No; UDI: 0735000201076120240508, 0735000201080820241217 GTIN: 07350002010761, 07350002010808 Serial Numbers: 15.1.0.852, 15.2.0.107 Software Revision: RayStation 2024A SP1, RayStation 2024A SP2 Expiration Date: 2030-04-150
Z-1109-2026Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 16.0.0 Software Version: RayStation 2024B Product Description: Radiation Therapy Treatment Planning System Component: No; Lot Code: UDI: 0735000201077820240625 GTIN: 07350002010778 Serial Numbers: 16.0.0.847 Software Revision: RayStation 2024B Expiration Date: 2029-06-280
Z-1110-2026Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 17.0.0, 17.0.1 Software Version: RayStation v2025, RayStation v2025 SP1 Product Description: Radiation Therapy Treatment Planning System Component: No; Lot Code: UDI: 0735000201082220250423, 0735000201094520250702 GTIN: 07350002010822, 07350002010945 Serial Numbers: 17.0.0.1270, 17.0.1.113 Software Revision: RayStation v2025, RayStation v2025 SP1 Expiration Date: 2030-10-220
Based on the official FDA remedy

What to do — step by step

  1. Check Software Version

    Review your RayStation software version to confirm if it is 17.0.0 or 17.0.1.

How this recall unfolded

Recall timeline

FDA published this recall 2 months after the firm started it.

1. Firm started the recall: Nov 28, 202512. FDA classified it Class II: Jan 16, 202623. Published in FDA’s Enforcement Report: Jan 28, 2026320252026
  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-1110-2026 (November 28, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1110-2026 to see it in context.
  • Plain-language summary written by qwen3:4b on August 17, 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