Use caution Medical device recall · FDA · Published November 18, 2019

ViewRay System Model 10000/20000: Radiation Treatment Misalignment Risk

ViewRay System models 10000 and 20000 for radiation treatment may have misalignment in dose registration causing incorrect radiation doses. Affected units include specific serial numbers listed in the recall notice.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1803-2020Medical device ViewRay ›

Use caution until it’s fixed

Registering dose and structures in the treatment delivery workflow could result in an alignment discrepancy between the imported previously delivered dose and the displayed patient anatomy and structures. The MRIdian TPDS software shows this misalignment to the user in the predicted dose-volume histogram (DVH). The misalignment impact may not be obvious to the user. During plan re-optimization the previously delivered dose would be incorrectly accounted for by the software. This may result in unexpectedly higher or lower dose than the intended dose calculated for the subsequent treatment plan. When this occurs in the treatment planning workflow, the registration fails to align the dose with the image and the user is unable to proceed.

Take action

Contact the company

Recalling firmViewray, Inc.815 E Middlefield Rd · Mountain View, CA 94043-4025

✎ GovInfoNow plain-language explainer

ViewRay's radiation treatment systems (models 10000 and 20000) may misalign radiation doses during treatment planning, potentially delivering incorrect radiation levels. This could lead to unintended higher or lower radiation doses than intended, risking patient safety. Read more at govinfonow.com/recall/66502-viewray-system-model-10000-20000-radiation-treatment-misalignment-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/66502-viewray-system-model-10000-20000-radiation-treatment-misalignment-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1803-2020

Cite this page

“ViewRay System Model 10000/20000: Radiation Treatment Misalignment Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/66502-viewray-system-model-10000-20000-radiation-treatment-misalignment-risk. Based on FDA recall #Z-1803-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1803-2020%22&limit=1).

The FDA announced on 2019-11-18 that Viewray, Inc. is recalling its ViewRay System models 10000 and 20000 due to a potential radiation dose discrepancy in the MRIdian TPDS software. The agency classified this as a Class II voluntary recall.

How to tell if you have it

Brand: ViewRay
Product: ViewRay System for radiation treatment
Model No.: 10000 and 20000
PN: PN11440 MRIdian System Treatment Planning and Delivery System (TPDS) software
Model No. 10000 Serial Nos.: 100,104,105,112,113
Model No. 20000 Serial Nos.: 101,102,107,108,200,201,203,204,206,207,209,211, 213,214,215,216,217,218,221,223,225,227,228,232,238,240,243, 244,247,250
Distribution: Worldwide, including US states MO, WI, CA, FL, MI, NY, IL, MA, and countries South Korea, Netherlands, Italy, Japan, Germany, UAE, Turkey, France, Israel, Denmark, Switzerland, United Kingdom

The hazard

Registering dose and structures in the treatment delivery workflow could result in an alignment discrepancy between the imported previously delivered dose and the displayed patient anatomy. This misalignment may not be obvious to the user and can cause the software to incorrectly account for previously delivered dose during plan re-optimization, potentially resulting in unexpectedly higher or lower doses than intended.

Context

GovInfoNow's records show Viewray, Inc. has had four other recalls since 2019-03-03, including a 2021-05-04 recall for French/German/Italian language anomalies and a 2020-10-20 recall regarding the risk of burn injury from overheating components. Other recent recalls of similar products include RayStation Software Version 15.2.0/15.1.3 (2025-11-28), RayStation Software Version 17.0.0-17.0.1 (2025-11-28), and RayStation/RayPlan Software 11A (2025-11-28), all citing radiation dose calculation risk.

How to tell if you have this one

Check if your ViewRay system has model numbers 10000 or 20000 with the listed serial numbers. The recall covers specific units identified by these model and serial number combinations.

Brand
ViewRay
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check System Model
Identify your ViewRay system's model number (10000 or 20000) and serial numbers to determine if it is affected.
Contact Manufacturer
Reach out to ViewRay, Inc. for further guidance on the recall and potential remedies.

Where it went and when

Where it was distributed

Distributed in 8 states, and outside the U.S.

FDA distribution: “Worldwide distribution. US states of MO, WI, CA, FL, MI, NY, MI, IL, and MA. South Korea, Netherlands, Italy, Japan, Germany, UAE, Turkey, France, Israel, Denmark, Switzerland, and United Kingdom. The distributors are assigned to…” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: California, Florida, Illinois, Massachusetts, Michigan, Missouri, New York, Wisconsin.

Recall timeline

FDA terminated this recall 3.3 years after the firm started it.

Nov 18, 2019Firm started the recall
Apr 27, 2020FDA classified it Class II
May 6, 2020Published in FDA’s Enforcement Report
Feb 22, 2023FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/66502-viewray-system-model-10000-20000-radiation-treatment-misalignment-risk">ViewRay System Model 10000/20000: Radiation Treatment Misalignment Risk (GovInfoNow)</a>

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-1803-2020 (November 18, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1803-2020 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.