# FDA recall Z-0408-2019

> **Accuray Incorporated** · Class II · device recall initiated 2018-09-26.

## Product

CyberKnife M6, Part Number 054000-004     The CyberKnife M6 Systems are indicated for treatment planning and image guided stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.

## Reason for recall

A robotics supplier notified Accuray of two manufacturing variations in the fastening of the in-line wrist and the casting of the wrist for the robot. The variation may result in premature failure of the component.

## Distribution

worldwide distribution.

## Key facts

- **Recall number:** Z-0408-2019
- **Recalling firm:** Accuray Incorporated
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-09-26
- **Report date:** 2018-11-14
- **Termination date:** 2021-05-12

- **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-0408-2019

## Citation

> AI Analytics. FDA recall Z-0408-2019. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/Z-0408-2019. Source: US FDA. Licensed CC0.

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