# FDA recall Z-1251-2019

> **Viewray, Inc.** · Class II · device recall initiated 2019-03-18.

## Product

MRIdian Linac Radiation Therapy System, Model 20000.

## Reason for recall

A discrepancy between optimization and planning forward dose calculation between adaptive optimizations and AQA dose calculations can occur.

## Distribution

Distribution was made to FL, IL, MI, MO,  NY, and WI.   There was no government/military distribution.  Foreign distribution was made to Denmark, France, Germany, Netherlands, South Korea, Switzerland, Turkey, UAE,

## Key facts

- **Recall number:** Z-1251-2019
- **Recalling firm:** Viewray, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-03-18
- **Report date:** 2019-05-08
- **Termination date:** 2022-06-16

- **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-1251-2019

## Citation

> AI Analytics. FDA recall Z-1251-2019. Retrieved 2026-06-30 from https://api.ai-analytics.org/recall/Z-1251-2019. Source: US FDA. Licensed CC0.

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