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Lower risk Medical device recall · FDA · Published May 4, 2021

ViewRay MRIdian Linac Software Recall: French/German/Italian Language Anomalies

ViewRay recalls specific software versions for French, German, and Italian language settings in their MRIdian Linac System due to treatment delivery anomalies. Affected units may require software updates or corrections to ensure safe radiation therapy planning.

🇺🇸 FDA recall #Z-1836-2021Medical deviceViewRay ›
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Recalling firmViewray, Inc.815 E Middlefield Rd · Mountain View, CA 94043-4025
✎ GovInfoNow plain-language explainer

What happened, in plain English

ViewRay is recalling certain software versions for their MRIdian Linac System that have language-specific issues in French, German, and Italian. These software anomalies could affect the accuracy of radiation treatment planning if not corrected. Read more at govinfonow.com/recall/62606-viewray-mridian-linac-software-recall-french-german-italian-language-anomalies.

Source Summary by GovInfoNow · govinfonow.com/recall/62606-viewray-mridian-linac-software-recall-french-german-italian-language-anomalies · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1836-2021

Cite this page

“ViewRay MRIdian Linac Software Recall: French/German/Italian Language Anomalies.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62606-viewray-mridian-linac-software-recall-french-german-italian-language-anomalies. Based on FDA recall #Z-1836-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1836-2021%22&limit=1).

Why it’s dangerous

The software anomalies in French, German, and Italian language versions can cause errors in treatment delivery planning. This might lead to inaccurate radiation dosing during stereotactic radiosurgery or precision radiotherapy procedures.

Who’s affected

Patients and medical professionals using ViewRay's MRIdian Linac System with specific software versions for French, German, or Italian language settings. Those with affected serial numbers are most at risk.

How to tell if you have this one

Check the serial number on your ViewRay MRIdian Linac System. French version affected serial numbers: 214, 215, 226, 240. German or Italian versions affected serial numbers: 203, 232, 108, 244.

  • Brand
    ViewRay
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Software Version

    Verify your software version by checking the serial number on the device. French versions with serial numbers 214, 215, 226, or 240 are affected. German or Italian versions with serial numbers 203, 232, 108, or 244 are affected.

How this recall unfolded

Recall timeline

FDA terminated this recall 2.5 years after the firm started it.

1. Firm started the recall: May 4, 202112. FDA classified it Class II: Jun 9, 202123. Published in FDA’s Enforcement Report: Jun 16, 202134. FDA terminated the recall: Oct 19, 2023420212023
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. 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-1836-2021 (May 4, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1836-2021 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA