RayStation 6 Service Pack 2 Software Error Risk in Radiation Therapy
RaySearch Laboratories recalls RayStation 6 Service Pack 2 (UDI #07350002010075) due to potential underestimation of radiation dose in cancer treatment calculations.
Lower-risk recall
Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calculation algorithms that could result in a local underestimation of expected dose.
Contact the company
What happened, in plain English
RaySearch Laboratories is recalling RayStation 6 Service Pack 2 software updates for radiation therapy systems. This update could cause the software to underestimate radiation doses during cancer treatment, potentially affecting treatment accuracy. Read more at govinfonow.com/recall/65123-raystation-6-service-pack-2-software-error-risk-in-radiation.
Source Summary by GovInfoNow · govinfonow.com/recall/65123-raystation-6-service-pack-2-software-error-risk-in-radiation · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2342-2020
Cite this page
“RayStation 6 Service Pack 2 Software Error Risk in Radiation Therapy.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/65123-raystation-6-service-pack-2-software-error-risk-in-radiation. Based on FDA recall #Z-2342-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2342-2020%22&limit=1).
Why it’s dangerous
The software contains an error in dose calculation algorithms that might cause the system to underestimate the radiation dose delivered to tumors. This could lead to under-treatment of cancer in some cases, though the risk is not immediate or severe in normal use.
Who’s affected
Medical professionals using RayStation 6 Service Pack 2 for radiation therapy or cancer treatment. Patients receiving radiation therapy with this software may be at risk if the dose calculation is inaccurate.
How to tell if you have this one
Check if your RayStation 6 software has build number 6.2.0.7. The recall applies to units with UDI # 07350002010075 used in radiation therapy and medical oncology.
- Brand
RaySearch Laboratories- Category
Medical device
All 15 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
Terminated- Distribution
US Nationwide distribution including in the states of Florida, Georgia, Utah, Virginia, California, Maryland, Arizona, Texas, Washington DC, Missouri, Massachusetts, Illinois, Oklahoma, New Jersey, Tennessee, and Louisiana.
| Recall number | Product, codes & lots |
|---|---|
| Z-2339-2020 | RayStation 4.0 to RayStation 5 Service Pack 2 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.; Build numbers: 4.0.3.4, 4.5.1.14, 4.7.2.5, 4.7.3.13, 4.7.4.4, 4.7.5.4, 4.7.6.7, 5.0.1.11, 5.0.2.35, |
| Z-2340-2020 | RayStation 5 Service Pack 3, UDI # 07350002010020 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.; UDI # 07350002010020 Build number: 5.0.3.17 |
| Z-2341-2020 | RayStation 6, UDI # 07350002010013 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.; UDI # 07350002010013 Build number: 6.0.0.24 |
| Z-2342-2020 | RayStation 6 Service Pack 2, UDI # 07350002010075 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.; UDI # 07350002010075 Build number: 6.2.0.7 |
| Z-2343-2020 | RayStation 6 Service Pack 3, UDI # 07350002010242 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.; UDI # 07350002010242 Build number: 6.3.0.6 |
| Z-2344-2020 | RayStation 8A, UDI # 07350002010112 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.; UDI # 07350002010112 Build number: 8.0.0.61 |
| Z-2345-2020 | RayStation 8A Service Pack 1, UDI # 07350002010136 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.; UDI # 07350002010136 Build number: 8.0.1.10 |
| Z-2346-2020 | RayStation 8B, UDI # 07350002010129 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.; UDI # 07350002010129 Build number: 8.1.0.47 |
| Z-2347-2020 | RayStation 8B Service Pack 1, UDI # 07350002010204 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.; UDI # 07350002010204 Build number: 8.1.1.8 |
| Z-2348-2020 | RayStation 8B Service Pack 2, UDI # 07350002010235 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.; UDI # 07350002010235 Build number: 8.1.2.5 |
| Z-2349-2020 | RayStation 9A, UDI # 07350002010174 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.; UDI # 07350002010174 Build number: 9.0.0.113 |
| Z-2350-2020 | RayStation 9B, UDI # 07350002010266 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.; UDI # 07350002010266 Build number: 9.1.0.933 |
| Z-2351-2020 | RayStation 9B Service Pack 1, UDI # 07350002010297 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.; UDI # 07350002010297 Build number: 9.2.0.483 |
| Z-2352-2020 | RayStation 6 Service Pack 1, UDI #s 07350002010037, 07350002010082 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.; UDI #s 07350002010037, 07350002010082 Build number: 6.1.1.2 |
| Z-2353-2020 | RayStation 7, UDI # 07350002010068 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.; UDI # 07350002010068 Build number: 7.0.0.19 |
What to do — step by step
Check Software Version
Verify your RayStation 6 software build number is 6.2.0.7 to determine if it's affected.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 15 states.
FDA distribution: “US Nationwide distribution including in the states of Florida, Georgia, Utah, Virginia, California, Maryland, Arizona, Texas, Washington DC, Missouri, Massachusetts, Illinois, Oklahoma, New Jersey, Tennessee, and Louisiana.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arizona, California, District of Columbia, Florida, Georgia, Illinois, Louisiana, Maryland, Massachusetts, Missouri, New Jersey, Oklahoma, Tennessee, Texas, Utah, Virginia.
Recall timeline
FDA terminated this recall 15 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Similar recalls
Latest medical device recalls
Keep exploring
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-2342-2020 (May 18, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2342-2020 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 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.