Viewray MRIdian Linac Radiation Therapy System Model 20000 Recall: Dose Calculation
Viewray recalls its MRIdian Linac Radiation Therapy System Model 20000 due to potential dose calculation discrepancies between adaptive optimizations and AQA calculations. Affected units have specific serial numbers listed in the recall.
Recall notice
A discrepancy between optimization and planning forward dose calculation between adaptive optimizations and AQA dose calculations can occur.
Contact the company
What happened, in plain English
Viewray is recalling its MRIdian Linac Radiation Therapy System Model 20000 because of a potential discrepancy in radiation dose calculations between adaptive treatments and quality assurance checks. This could affect treatment accuracy for cancer patients. Read more at govinfonow.com/recall/68611-viewray-mridian-linac-radiation-therapy-system-model-20000-recall-dose.
Source Summary by GovInfoNow · govinfonow.com/recall/68611-viewray-mridian-linac-radiation-therapy-system-model-20000-recall-dose · Updated August 20, 2026 · FDA enforcement record: FDA #Z-1251-2019
Cite this page
“Viewray MRIdian Linac Radiation Therapy System Model 20000 Recall: Dose Calculation.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/68611-viewray-mridian-linac-radiation-therapy-system-model-20000-recall-dose. Based on FDA recall #Z-1251-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1251-2019%22&limit=1).
Why it’s dangerous
The system may show a difference in radiation dose calculations between treatment planning and actual delivery. This discrepancy could lead to incorrect radiation doses being delivered during cancer treatment, potentially affecting treatment effectiveness or safety.
Who’s affected
Patients receiving radiation therapy using this specific model of Viewray system are affected. Medical facilities that use the Model 20000 for cancer treatment are most at risk.
How to tell if you have this one
Check if your Viewray MRIdian Linac Radiation Therapy System has the Model 20000 with serial numbers listed: 101, 107, 201, 202, 203, 204, 205, 206, 209, 211, 213, 214, 217, 221, 223, 225, 228.
- Brand
Viewray- Category
Medical device
What to do — step by step
Check Serial Number
Verify your device's serial number against the list: 101, 107, 201, 202, 203, 204, 205, 206, 209, 211, 213, 214, 217, 221, 223, 225, 228.
Where it went and when
Where it was distributed
Distributed in 6 states, and outside the U.S.
FDA distribution: “Distribution was made to FL, IL, MI, MO, NY, and WI. There was no government/military distribution. Foreign distribution was made to Denmark, France, Germany, Netherlands, South Korea, Switzerland, Turkey, UAE,” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Florida, Illinois, Michigan, Missouri, New York, Wisconsin.
Recall timeline
FDA terminated this recall 3.2 years 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.
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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-1251-2019 (March 18, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1251-2019 to see it in context.
- Plain-language summary written by qwen3:4b on August 20, 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.