# FDA recall Z-1023-2025

> **Accuray Incorporated** · Class II · device recall initiated 2024-12-23.

## Product

CyberKnife Treatment Delivery System, REF 0660000    The CyberKnife System may be labeled as CyberKnife M6TM or VSI TM Robotic Surgery System. The CyberKnife Treatment Delivery System is indicated for image-guided stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated.

## Reason for recall

Snap rings may become partially or completed detached from the shafts within the internal mechanism. Uncontrolled rotation may occur on the left and right roll axes when the rings are removed or damaged.

## Distribution

Worldwide - US Nationwide distribution.

## Key facts

- **Recall number:** Z-1023-2025
- **Recalling firm:** Accuray Incorporated
- **Classification:** Class II
- **Product type:** device
- **Status:** Completed
- **Initiation date:** 2024-12-23
- **Report date:** 2025-02-05

- **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-1023-2025

## Citation

> AI Analytics. FDA recall Z-1023-2025. Retrieved 2026-07-15 from https://api.ai-analytics.org/recall/Z-1023-2025. Source: US FDA. Licensed CC0.

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