# FDA recall Z-0286-2018

> **Accuray Incorporated** · Class II · device recall initiated 2017-11-17.

## Product

Hi-Art(R) System, Model Number H-000-0003    Product Usage:  The TomoTherapy treatment system is intended to be used as an integrated system for t he planning and precise delivery of radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery to tumors or other targeted tissues while minimizing the delivery of radiation to vital healthy tissues. The megavoltage x-ray radiation is delivered in a rotational, non-rotational, modulated (IMRT), or non- modulated (non-IMRT/3 dimensional conformal) format in accordance with the physicians prescribed and approved plan.

## Reason for recall

Uncontrolled couch Z-axis movement (descent)

## Distribution

Worldwide Distribution

## Key facts

- **Recall number:** Z-0286-2018
- **Recalling firm:** Accuray Incorporated
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-11-17
- **Report date:** 2018-01-03
- **Termination date:** 2021-07-25

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Madison, WI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0286-2018

## Citation

> AI Analytics. FDA recall Z-0286-2018. Retrieved 2026-06-08 from https://api.ai-analytics.org/recall/Z-0286-2018. Source: US FDA. Licensed CC0.

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