# FDA recall Z-0676-2020

> **Viewray, Inc.** · Class II · device recall initiated 2019-03-03.

## Product

MRIdian Linac Radiation Therapy System Model 10000 and 20000

## Reason for recall

Issue with transferring treatment regiment from one system to another.  Adequate instructions for transferring treatment plan(s) are not provided within the operator's manual or within the software operating system.

## Distribution

US - CA, FL, IL, MI, MO, NY, and WI    OUS: Denmark, France, Germany, Italy, Japan, Netherlands, Turkey, South Korea, and UAE

## Key facts

- **Recall number:** Z-0676-2020
- **Recalling firm:** Viewray, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-03-03
- **Report date:** 2019-12-18
- **Termination date:** 2021-04-28

- **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-0676-2020

## Citation

> AI Analytics. FDA recall Z-0676-2020. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0676-2020. Source: US FDA. Licensed CC0.

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