ViewRay MRIdian System: Model No — Class II medical device recall Z-0481-2021
Terminated recall by Viewray, Inc., reported 2020-12-02, distributed nationwide. There is a potential that components of the receive coil can reach elevated temperatures which has the potenti
| Recall number | Z-0481-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Viewray, Inc., Mountain View, CA, United States |
| Recall initiated | 2020-10-20 |
| Classified | 2020-11-20 |
| Reported by FDA | 2020-12-02 |
| Terminated | 2023-10-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | DE, DK, FR, GB, IL, IT, NL, TW |
| Quantity | 3 systems |
| Model numbers | 10000 |
Product
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.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0481-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.