# FDA recall Z-1836-2021

> **Viewray, Inc.** · Class II · device recall initiated 2021-05-04.

## Product

ViewRay MRIdian Linac System: Model No. 20000-01 software, CE 0086 - Product Usage:  intended to be used for planning external beam irradiation with photon beams and delivering stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated, in conjunction with the ViewRay System, an MRI image-guided radiation therapy system.

## Reason for recall

Software anomalies affecting the French, German and Italian versions of treatment delivery system (TDS) software.

## Distribution

International distribution only to the countries of France, Germany, Italy, and Switzerland.

## Key facts

- **Recall number:** Z-1836-2021
- **Recalling firm:** Viewray, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-05-04
- **Report date:** 2021-06-16
- **Termination date:** 2023-10-19

- **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-1836-2021

## Citation

> AI Analytics. FDA recall Z-1836-2021. Retrieved 2026-07-16 from https://api.ai-analytics.org/recall/Z-1836-2021. Source: US FDA. Licensed CC0.

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