Use cautionMedical device recall · FDA · Published October 20, 2020
ViewRay MRIdian System Recall: Burn Risk from Overheating Components
ViewRay recalls its MRIdian System Model 10000 due to potential overheating of receive coil components that could cause burns during use. Affected units include all lots/serial numbers sold globally.
There is a potential that components of the receive coil can reach elevated temperatures which has the potential to cause a burn injury to the patient or user.
Take action
Contact the company
📍Recalling firmViewray, Inc.815 E Middlefield Rd · Mountain View, CA 94043-4025
“ViewRay MRIdian System Recall: Burn Risk from Overheating Components.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64068-viewray-mridian-system-recall-burn-risk-from-overheating-components. Based on FDA recall #Z-0481-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0481-2021%22&limit=1).
The FDA announced on Oct. 20, 2020, that Viewray, Inc. is recalling its MRIdian System due to a potential burn injury hazard. The agency stated the recall addresses components of the receive coil reaching elevated temperatures.
How to tell if you have it
Brand: ViewRay
Product: MRIdian System
Model No.: 10000, CE
Rated Supply Voltage: 380/480 VAC
Frequency Range: 50/60 Hz
Rated Input: 210 A
Quantity: 3 systems
The hazard
According to the FDA, components of the receive coil can reach elevated temperatures, which has the potential to cause a burn injury to the patient or user.
Context
GovInfoNow's records show Viewray, Inc. has had four other recalls since March 3, 2019. Other recent recalls of similar products include I.T.S. DUL/UOL Systems Risk MRI Heating (Jan. 23, 2026) and BD Pyxis MedStation ES REF 323 Medication Cabinet Recall (April 30, 2026).
How to tell if you have this one
Check for the Model No. 10000 with CE marking and rated supply voltage of 380/480 VAC. All lots and serial numbers are affected by this recall.
Brand
ViewRay
Category
Medical device
FDA recall event · 2 products
All 2 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
Worldwide Distribution: US (nationwide) to states of: CA, NY, FL, IL, MI, MO, OR, WI and OUS countries of: France, Germany, Italy, United Kingdom, Taiwan, Netherlands, Israel, and Denmark.
Recall number
Product, codes & lots
Quantity
Z-0481-2021
ViewRay MRIdian System: Model No. 10000, CE, Rated Supply Voltage - 380/480 VAC, 3 - Frequency Range (Hertz) - 50/60 Hz, Rated Input in Amperes - 210 A, UDI. The MRIdian system and the MRIdian Linac system, with magnetic resonance imaging capabilities, is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.; All Lots/Serial Numbers
3 systems
Z-0482-2021
ViewRay MRIdian Linac System: Model No. 20000, CE, Rated Supply Voltage - 380/480 VAC, 3 - Frequency Range (Hertz) - 50/60 Hz, Rated Input in Amperes - 210 A, UDI. The MRIdian system and the MRIdian Linac system, with magnetic resonance imaging capabilities, is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.; All Lots/Serial Numbers
35 units
Based on the official FDA remedy
What to do — step by step
Check Device Model
Verify the model number is 10000 with CE marking and rated supply voltage of 380/480 VAC.
Contact Manufacturer
Reach out to ViewRay directly for specific instructions on next steps for affected units.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 8 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide Distribution: US (nationwide) to states of: CA, NY, FL, IL, MI, MO, OR, WI and OUS countries of: France, Germany, Italy, United Kingdom, Taiwan, Netherlands, Israel, and Denmark.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, Florida, Illinois, Michigan, Missouri, New York, Oregon, Wisconsin.
Recall timeline
FDA terminated this recall 3 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.
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-0481-2021 (October 20, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0481-2021 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.