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Unrated Medical device recall · FDA · Published August 8, 2025

RayStation Software Version 12.0.0.932: Unique DICOM IDs Risk

RaySearch recalls RayStation software versions 12.0.0.932 and others due to potential duplicate DICOM identifiers, which could cause treatment errors in radiation therapy. Affected users should 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-2492-2025Medical deviceRaySearch ›
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Contact the company

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

RaySearch recalls specific versions of its RayStation radiation therapy software because they may generate duplicate DICOM identifiers. This could lead to treatment errors if the software misidentifies patient data during radiation therapy sessions. Read more at govinfonow.com/recall/51649-raystation-software-version-12-0-0-932-unique-dicom-ids.

Source Summary by GovInfoNow · govinfonow.com/recall/51649-raystation-software-version-12-0-0-932-unique-dicom-ids · Updated August 17, 2026 · FDA enforcement record: FDA #Z-2492-2025

Cite this page

“RayStation Software Version 12.0.0.932: Unique DICOM IDs Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/51649-raystation-software-version-12-0-0-932-unique-dicom-ids. Based on FDA recall #Z-2492-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2492-2025%22&limit=1).

The FDA announced on Aug. 8, 2025, that RaySearch Laboratories AB is recalling RayStation radiation therapy treatment planning software due to non-unique DICOM UIDs. The recall affects five specific software versions distributed worldwide.

How to tell if you have it

  • RayStation 11B, Software Version: 12.0.0.932, UDI: 0735000201042620211208
  • RayStation 11B Service Pack 1, Software Version: 12.1.0.1221, UDI: 0735000201049520220312
  • RayStation 11B Service Pack 2, Software Version: 12.0.3.68, UDI: 0735000201050120220422
  • RayStation 11B Service Pack 3, Software Version: 12.0.4.12, UDI: 0735000201060020220620
  • RayStation 11B Service Pack Toshiba 1, Software Version: 12.3.0.119, UDI: 0735000201057020221222

The hazard

According to the FDA, DICOM SOP Instance UID and Series Instance UID from RayGateway are not guaranteed to be unique. This interface connects to Accuray's iDMS system.

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 notice regarding RayCare 2:024A SP1 Oncology Software data loss risk, a Nov. 28, 2025 recall for RayStation radiation dose calculation errors, and a Jan. 16, 2025 alert about density uncertainty in RayStation Software Version 12A. Other recent recalls of similar products include Elekta Leksell GammaPlan 11.1 Software Recall (Dec. 12, 2025), Intelerad InteleShare Software Recall (Nov. 18, 2025), and Elekta Leksell GammaPlan software version 11.3/11.4 recall (Dec. 12, 2025).

How to tell if you have this one

Check if your RayStation software version is listed: 12.0.0.932, 12.1.0.1221, 12.0.3.68, 12.0.4.12, or 12.3.0.119. The recall covers versions sold between 2021 and 2028.

  • Brand
    RaySearch
  • 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
    Worldwide - US Nationwide distribution in the states of AL, CA, FL, GA, IL, IA, KY, LA, MD, MN, MS, NY, NC, OH, OK, SC, WA, WI and the countries of Canada, China, Colombia, France, Germany, Hong Kong S.A.R., China, Italy, Japan, Netherlands, Poland, Spain, Sweden, Switzerland, ENG, Thailand, Turkey, UK, Ukraine.
Recall numberProduct, codes & lotsQuantity
Z-2487-2025RayStation with the following product descriptions: 1. RayStation 7, Software Version: 7.0.0.19. 2. RayStation 8A, Software Version: 8.0.0.61. 3. RayStation 8A Service Pack 1, Software Version: 8.0.1.10. Product Description: Radiation Therapy Treatment Planning System.; 1. Software Version: 7.0.0.19, UDI: 0735000201006820171130. 2. Software Version: 8.0.0.61, UDI: 0735000201011220180608. 3. Software Version: 8.0.1.10, UDI: 0735000201013620180928. Expiration Date: 2023-10-041
Z-2488-2025RayStation with the following product descriptions: 1. RayStation 8B, Software Version: 8.1.0.47. 2. RayStation 8B Service Pack 1, Software Version: 8.1.1.8. 3. RayStation 8B Service Pack 2, Software Version: 8.1.2.5. 4. RayStation 9A, Software Version: 9.0.0.113. 5. RayStation 9A Service Pack 1, Software Version: 9.0.1.142. Product Description: Radiation Therapy Treatment Planning System.; 1. Software Version: 8.1.0.47, UDI: 0735000201012920181209. 2. Software Version: 8.1.1.8, UDI: 0735000201020420190214. 3. Software Version: 8.1.2.5, UDI: 0735000201023520190524. 4. Software Version: 9.0.0.113, UDI: 0735000201017420190612. 5. Software Version: 9.0.1.142, UDI: 0735000201048820220420. Expiration Date: 2027-12-152
Z-2489-2025RayStation with the following product descriptions: 1. RayStation 9B, Software Version: 9.1.0.933. 2. RayStation 9B Service Pack 1, Software Version: 9.2.0.483. 3. RayStation 10A, Software Version: 10.0.0.1154. 4. RayStation 10A Service Pack 1, Software Version: 10.0.1.52. 5. RayStation 10A Service Pack 2, Software Version: 10.0.2.10. Product Description: Radiation Therapy Treatment Planning System.; 1. Software Version: 9.1.0.933, UDI: 0735000201026620191220. 2. Software Version: 9.2.0.483, UDI: 0735000201029720200310. 3. Software Version: 10.0.0.1154, UDI: 0735000201030320200526. 4. Software Version: 10.0.1.52, UDI: 0735000201036520200526. 5. Software Version: 10.0.2.10, UDI: 0735000201065520220608. Expiration Date: 2025-06-1626
Z-2490-2025RayStation with the following product descriptions: 1. RayStation 10B, Software Version: 10.1.0.613. 2. RayStation 10B Service Pack 1, Software Version: 10.1.1.54. Product Description: Radiation Therapy Treatment Planning System.; 1. Software Version: 10.1.0.613, UDI: 0735000201031020201216. 2. Software Version: 10.1.1.54, UDI: 0735000201047120220128. Expiration Date: 2027-02-013
Z-2491-2025RayStation with the following product descriptions: 1. RayStation 11A, Software Version: 11.0.0.951. 2. RayStation 11A Service Pack 1, Software Version: 11.0.1.29. 3. RayStation 11A Service Pack 2, Software Version: 11.0.3.116. 4. RayStation 11A Service Pack 3, Software Version: 11.0.4.15. Product Description: Radiation Therapy Treatment Planning System.; 1. Software Version: 11.0.0.951, UDI: 0735000201038920210518. 2. Software Version: 11.0.1.29, UDI: 0735000201043320210610. 3. Software Version: 11.0.3.116, UDI: 0735000201044020210916. 4. Software Version: 11.0.4.15, UDI: 0735000201063120220616. Expiration Date: 2027-06-223
Z-2492-2025RayStation with the following product descriptions: 1. RayStation 11B, Software Version: 12.0.0.932. 2. RayStation 11B Service Pack 1, Software Version: 12.1.0.1221. 3. RayStation 11B Service Pack 2, Software Version: 12.0.3.68. 4. RayStation 11B Service Pack 3, Software Version: 12.0.4.12. 5. RayStation 11B Service Pack Toshiba 1, Software Version: 12.3.0.119. Product Description: Radiation Therapy Treatment Planning System.; 1. Software Version: 12.0.0.932, UDI: 0735000201042620211208. 2. Software Version: 12.1.0.1221, UDI: 0735000201049520220312. 3. Software Version: 12.0.3.68, UDI: 0735000201050120220422. 4. Software Version: 12.0.4.12, UDI: 0735000201060020220620. 5. Software Version: 12.3.0.119, UDI: 0735000201057020221222. Expiration Date: 2028-03-206
Z-2493-2025RayStation with the following product descriptions: 1. RayStation 12A, Software Version: 13.0.0.1547. 2. RayStation 12A Service Pack 1, Software Version: 13.1.0.144. 3. RayStation 12A Service Pack 2, Software Version: 13.1.1.89. Product Description: Radiation Therapy Treatment Planning System.; 1. Software Version: 13.0.0.1547, UDI: 0735000201054920220616. 2. Software Version: 13.1.0.144, UDI: 0735000201067920221007. 3. Software Version: 13.1.1.89, UDI: 0735000201073020230913. Expiration Date: 2028-07-0713
Z-2494-2025RayStation with the following product descriptions: 1. RayStation 6 Service Pack 1, Software Version: 6.1.1.2. 2. RayStation 6 Service Pack 2, Software Version: 6.2.0.7. 3. RayStation 6 Service Pack 3, Software Version: 6.3.0.6. Product Description: Radiation Therapy Treatment Planning System.; 1. Software Version: 6.1.1.2, UDI: 0735000201008220170529. 2. Software Version: 6.2.0.7, UDI: 0735000201007520170630. 3. Software Version: 6.3.0.6, UDI: 0735000201024220190923. Expiration Date: 2024-10-180
Z-2495-2025RayStation with the following product descriptions: 1. RayStation 2023B, Software Version: 14.0.0.3338. 2. RayStation 2024A, Software Version: 15.0.0.430. 3. RayStation 2024A SP3, Software Version: 15.1.3.10. Product Description: Radiation Therapy Treatment Planning System.; 1. Software Version: 14.0.0.3338, UDI: 0735000201055620230630. 2. Software Version: 15.0.0.430, UDI: 0735000201072320231213. 3. Software Version: 15.1.3.10, UDI: 0735000201087720241106. Expiration Date: 2030-02-2149
Based on the official FDA remedy

What to do — step by step

  1. Check Software Version

    Review your RayStation software version to see if it matches the recalled versions listed in the notice.

  2. Contact RaySearch

    Reach out to RaySearch Laboratories for guidance on next steps and potential updates to the software.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 18 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: named in the noticeWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: named in the noticeMNIllinois: named in the noticeILWisconsin: named in the noticeWIMichigan: nationwideMINew York: named in the noticeNYRhode Island: nationwideRIMassachusetts: nationwideMAOregon: nationwideORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: named in the noticeIAIndiana: nationwideINOhio: named in the noticeOHPennsylvania: nationwidePANew Jersey: nationwideNJConnecticut: nationwideCTCalifornia: named in the noticeCAUtah: nationwideUTColorado: nationwideCONebraska: nationwideNEMissouri: nationwideMOKentucky: named in the noticeKYWest Virginia: nationwideWVVirginia: nationwideVAMaryland: named in the noticeMDDelaware: nationwideDEArizona: nationwideAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: nationwideARTennessee: nationwideTNNorth Carolina: named in the noticeNCSouth Carolina: named in the noticeSCDistrict of Columbia: nationwideDCOklahoma: named in the noticeOKLouisiana: named in the noticeLAMississippi: named in the noticeMSAlabama: named in the noticeALGeorgia: named in the noticeGAHawaii: nationwideHITexas: nationwideTXFlorida: named in the noticeFL

FDA distribution: “Worldwide - US Nationwide distribution in the states of AL, CA, FL, GA, IL, IA, KY, LA, MD, MN, MS, NY, NC, OH, OK, SC, WA, WI and the countries of Canada, China, Colombia, France, Germany, Hong Kong S.A.R., China, Italy, Japan,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, California, Florida, Georgia, Illinois, Iowa, Kentucky, Louisiana, Maryland, Minnesota, Mississippi, New York, North Carolina, Ohio, Oklahoma, South Carolina, Washington, Wisconsin.

Recall timeline

FDA published this recall 33 days after the firm started it.

1. Firm started the recall: Aug 8, 202512. FDA classified it Class II: Sep 2, 202523. Published in FDA’s Enforcement Report: Sep 10, 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-2492-2025 (August 8, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2492-2025 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