# FDA recall Z-0482-2021

> **Viewray, Inc.** · Class II · device recall initiated 2020-10-20.

## Product

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.

## 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.

## 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.

## Key facts

- **Recall number:** Z-0482-2021
- **Recalling firm:** Viewray, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-10-20
- **Report date:** 2020-12-02
- **Termination date:** 2023-10-13

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Mountain View, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0482-2021

## Citation

> AI Analytics. FDA recall Z-0482-2021. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/Z-0482-2021. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*