Lower riskMedical device recall · FDA · Published March 3, 2019
Viewray MRIdian Linac Radiation Therapy System Recall: Transfer Errors Risk Treatment
Viewray recalls specific MRIdian Linac models due to inadequate instructions for transferring radiation treatment plans between systems, potentially causing treatment errors. Affected units include Model 10000 and 20000 with listed serial numbers.
Issue with transferring treatment regiment from one system to another. Adequate instructions for transferring treatment plan(s) are not provided within the operator's manual or within the software operating system.
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Contact the company
📍Recalling firmViewray, Inc.815 E Middlefield Rd · Mountain View, CA 94043-4025
✎ GovInfoNow plain-language explainer
Viewray is recalling certain MRIdian Linac Radiation Therapy Systems because the operator's manual and software don't provide clear instructions for transferring treatment plans between systems. This could lead to inconsistent radiation treatments if users try to switch systems without proper guidance. Read more at govinfonow.com/recall/68916-viewray-mridian-linac-radiation-therapy-system-recall-transfer-errors-risk.
“Viewray MRIdian Linac Radiation Therapy System Recall: Transfer Errors Risk Treatment.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/68916-viewray-mridian-linac-radiation-therapy-system-recall-transfer-errors-risk. Based on FDA recall #Z-0676-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0676-2020%22&limit=1).
The FDA announced on March 3, 2019, that Viewray, Inc. voluntarily recalled MRIdian Linac Radiation Therapy Systems Models 10000 and 20000 due to a hazard involving the transfer of treatment regimens between systems. The agency issued recall number Z-0676-2020 for the Class II device.
How to tell if you have it
Brand: Viewray
Product: MRIdian Linac Radiation Therapy System Model 10000 and 20000
The recall addresses an issue with transferring treatment regimens from one system to another. The record states that adequate instructions for transferring treatment plans are not provided within the operator's manual or within the software operating system.
Context
GovInfoNow's records show Viewray, Inc. has had four other recalls since March 18, 2019. Other recent recalls of similar products include RayStation/RayPlan Software Recall (Nov. 28, 2025), Elekta MOSAIQ Oncology System Software Recall (May 21, 2026), and RayStation/RayPlan Software 11A Recalls (Nov. 28, 2025).
How to tell if you have this one
Check if your device is Model 10000 or 20000 with serial numbers listed in the recall notice (100-113, 201-225). The device listing numbers D158423 and D297999 are also associated with these models.
Brand
Viewray
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Device Model
Identify if your device is Model 10000 or 20000 with the listed serial numbers (100-113, 201-225).
Where it went and when
Where it was distributed
Distributed in 7 states, and outside the U.S.
Listed by the agency
Not listed
FDA distribution: “US - CA, FL, IL, MI, MO, NY, and WI OUS: Denmark, France, Germany, Italy, Japan, Netherlands, Turkey, South Korea, and UAE” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: California, Florida, Illinois, Michigan, Missouri, New York, Wisconsin.
Recall timeline
FDA terminated this recall 2.2 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Is there a risk of serious injury from this issue?
The recall describes a potential for inconsistent treatment, but no specific injury mechanism is mentioned. This is considered low risk as it does not involve immediate physical harm.
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-0676-2020 (March 3, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0676-2020 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.