# FDA recall Z-1803-2020

> **Viewray, Inc.** · Class II · device recall initiated 2019-11-18.

## Product

ViewRay System: Model No. 10000 and 20000 for radiation treatment.  PN11440  MRIdian System Treatment Planning and Delivery System (TPDS) software

## Reason for recall

Registering dose and structures in the treatment delivery workflow could result in an alignment discrepancy between the imported previously delivered dose and the displayed patient anatomy and structures. The MRIdian TPDS software shows this misalignment to the user in the predicted dose-volume histogram (DVH). The misalignment impact may not be obvious to the user.  During plan re-optimization the previously delivered dose would be incorrectly accounted for by the software. This may result in unexpectedly higher or lower dose than the intended dose calculated for the subsequent treatment plan. When this occurs in the treatment planning workflow, the registration fails to align the dose with the image and the user is unable to proceed.

## Distribution

Worldwide distribution.  US states of MO, WI, CA, FL, MI, NY, MI, IL, and MA.   South Korea, Netherlands, Italy, Japan, Germany, UAE, Turkey, France, Israel, Denmark, Switzerland, and United Kingdom.      The distributors are assigned to applicable regions. Firm send the Urgent Device Corrections to them and they forwarded them to the sites.

## Key facts

- **Recall number:** Z-1803-2020
- **Recalling firm:** Viewray, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-11-18
- **Report date:** 2020-05-06
- **Termination date:** 2023-02-22

- **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-1803-2020

## Citation

> AI Analytics. FDA recall Z-1803-2020. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1803-2020. Source: US FDA. Licensed CC0.

---

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