# FDA recall Z-0785-2021

> **Accuray Incorporated** · Class II · device recall initiated 2020-12-10.

## Product

TomoTherapy Treatment Delivery System with iDMS - Product Usage: used as an integrated system for the 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 tissue.

## Reason for recall

"MLC tickle error" may result in the delivered dose to effectively rotate from the planned dose.

## Distribution

Worlwide distribution - US Nationwide distribution including in the states of CA, FL, IL, ND, NJ, OK, UT and the countries of Australia, China, Italy, Switzerland, United Arab Emirates.

## Key facts

- **Recall number:** Z-0785-2021
- **Recalling firm:** Accuray Incorporated
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-12-10
- **Report date:** 2021-01-13
- **Termination date:** 2022-09-26

- **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-0785-2021

## Citation

> AI Analytics. FDA recall Z-0785-2021. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/Z-0785-2021. Source: US FDA. Licensed CC0.

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