RayStation 13.0.0.1547 Software Recall: Potential for Too High SSD Values
RaySearch Laboratories recalls specific versions of RayStation radiation therapy software due to potential for reported SSD values to be too high. Affected users should contact the company for details.
Lower-risk recall
Potential for reported SSD to be too high.
Contact the company
What happened, in plain English
RaySearch Laboratories is recalling specific versions of their RayStation radiation therapy software. The recall is due to a potential issue where the software might report an SSD (safety distance) value that is too high, which could affect treatment accuracy. Read more at govinfonow.com/recall/55682-raystation-13-0-0-1547-software-recall-potential-for-too.
Source Summary by GovInfoNow · govinfonow.com/recall/55682-raystation-13-0-0-1547-software-recall-potential-for-too · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1750-2024
Cite this page
“RayStation 13.0.0.1547 Software Recall: Potential for Too High SSD Values.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/55682-raystation-13-0-0-1547-software-recall-potential-for-too. Based on FDA recall #Z-1750-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1750-2024%22&limit=1).
Why it’s dangerous
The software may report an SSD (safety distance) value that is too high. This could lead to inaccurate radiation treatment planning, potentially affecting patient safety. However, the recall does not indicate immediate danger to users.
Who’s affected
Healthcare professionals using RaySearch Laboratories' RayStation software for radiation therapy planning are affected. Those with the specific software versions listed in the recall are most at risk.
How to tell if you have this one
Check if your RayStation software version is 13.0.0.1547, 13.1.0.144, or 13.1.1.89. The software was sold with specific expiration dates and serial numbers listed in the recall notice.
- Brand
RaySearch Laboratories- Product
RayStation 13.0.0.1547, 13.1.0.144 & 13.1.1.89. Radiation Therapy Treatment Planning System- Category
Medical device
All 12 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 Algeria, Australia, Austria, Bahrain, Belgium, Canada, China, Colombia, Cyprus, Czech Republic, Denmark, Egypt, Estonia, France, Germany, Hungary, India, Indonesia, Iran, Israel, Italy, Japan, Korea, Malaysia, Morocco, Netherlands, New Zealand, Norway, Poland, Qatar, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UAE, UK.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-1741-2024 | RayStation 7.0.0.19. Radiation Therapy Treatment Planning System.; UDI: 0735000201006820171130; GTIN: 07350002010068; Serial Numbers: 7.0.0.19; Expiration Date: 2022-10-04. | 14 units |
| Z-1742-2024 | RayStation 8.0.0.61, 8.0.1.10. Radiation Therapy Treatment Planning System.; UDI: 0735000201011220180608 and 0735000201013620180928; GTIN: 07350002010112 and 07350002010136; Serial Numbers: 8.0.0.61 and 8.0.1.10 Software Revisions: RayStation/RayPlan 8A and 8A Service Pack 1; Expiration Date: 2023-10-04. | 9 units |
| Z-1743-2024 | RayStation 8.1.0.47, 8.1.1.8 and 8.1.2.5. Radiation Therapy Treatment Planning System.; UDI: 0735000201011220180608 and 0735000201013620180928; GTIN: 07350002010112 and 07350002010136; Serial Numbers: 8.0.0.61 and 8.0.1.10; Expiration Date: 2024-06-05. | 5 units |
| Z-1744-2024 | RayStation 9.0.0.113 and 9.0.1.142. Radiation Therapy Treatment Planning System.; UDI: 0735000201017420190612 and 0735000201048820220420; GTIN: 07350002010174 and 07350002010488; Serial Numbers: 9.0.0.113 and 9.0.1.142; Expiration Date: 2027-12-15. | 63 units |
| Z-1745-2024 | RayStation 9.1.0.933 and 9.2.0.483. Radiation Therapy Treatment Planning System.; UDI: 0735000201026620191220 and 0735000201029720200310; GTIN: 07350002010266 and 07350002010297; Serial Numbers: 9.1.0.933 and 9.2.0.483; Expiration Date: 2025-03-31. | 11 units |
| Z-1746-2024 | RayStation 10.0.0.1154, 10.0.1.52 & 10.0.2.10. Radiation Therapy Treatment Planning System.; UDI: 0735000201030320200526, 0735000201036520200526 and 0735000201065520220608; GTIN: 07350002010303, 07350002010365 and 07350002010655; Serial Numbers: 10.0.0.1154, 10.0.1.52 and 10.0.2.10; Expiration Date: 2025-06-16. | 213 units |
| Z-1747-2024 | RayStation 10.1.0.613 and 10.1.1.54. Radiation Therapy Treatment Planning System.; UDI: 0735000201031020201216 and 0735000201047120220128; GTIN: 07350002010310 and 07350002010471; Serial Numbers: 10.1.0.613 and 10.1.1.54; Expiration Date: 2027-02-01. | 18 units |
| Z-1748-2024 | RayStation 11.0.0.951, 11.0.1.29, 11.0.3.116 & 11.0.4.15. Radiation Therapy Treatment Planning System.; 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; Expiration Date: 2027-06-22. | 10 units |
| Z-1749-2024 | RayStation 12.0.0.932, 12.1.0.1221, 12.0.3.68, 12.0.4.12 &12.3.0.119. 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 and 12.3.0.119; Expiration Date: 2028-03-20. | 66 units |
| Z-1750-2024 | RayStation 13.0.0.1547, 13.1.0.144 & 13.1.1.89. Radiation Therapy Treatment Planning System.; UDI: 0735000201054920220616, 0735000201067920221007 and 0735000201073020230913; GTIN: 07350002010549, 07350002010679 and 07350002010730; Serial Numbers: 13.0.0.1547, 13.1.0.144 and 13.1.1.89; Expiration Date: 2028-10-05. | 128 units |
| Z-1751-2024 | RayStation 14.0.0.3338. Radiation Therapy Treatment Planning System.; UDI: 0735000201055620230630; GTIN: 07350002010556; Serial Numbers: 14.0.0.3338; Expiration Date: 2028-07-07. | 49 units |
| Z-1752-2024 | RayStation 15.0.0.430. Radiation Therapy Treatment Planning System.; UDI: 0735000201072320231213; GTIN: 07350002010723; Serial Numbers: 15.0.0.430; Expiration Date: 2028-12-21. | 3 units |
What to do — step by step
Check Software Version
Identify your RayStation software version by checking the version number in the software interface.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Worldwide distribution - US Nationwide and the countries of Algeria, Australia, Austria, Bahrain, Belgium, Canada, China, Colombia, Cyprus, Czech Republic, Denmark, Egypt, Estonia, France, Germany, Hungary, India, Indonesia, Iran, Israel,…” 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.
- Firm started the recall
- FDA classified it Class II
- 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-1750-2024 (March 28, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1750-2024 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.