# FDA recall Z-1697-2019

> **Accuray Incorporated** · Class II · device recall initiated 2018-04-10.

## Product

CyberKnife VSI, Part Numbers:  a) 032500-010:  CyberKnife VSI 9.6.x Robotic Radiosurgery System for Japan  b) 033000-010:  CyberKnife VSI Robotic Radiosurgery System

## Reason for recall

There is an unintended drop of a secondary collimator housing that can occur during housing Xchange(TM) workflows.  Specifically, during an automated housing Xchange, an interlock may interrupt this operation causing the collimator housing to partially attach.

## Distribution

US & Italy, United Kingdom, Switzerland, Belgium, Canada, Germany, France, Japan, Poland, Netherlands, Luxembourg, Australia, Qatar, Latvia, Portugal, India, Hungary, Turkey, United Arab Emirates, Thailand

## Key facts

- **Recall number:** Z-1697-2019
- **Recalling firm:** Accuray Incorporated
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-04-10
- **Report date:** 2019-06-12
- **Termination date:** 2021-04-01

- **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-1697-2019

## Citation

> AI Analytics. FDA recall Z-1697-2019. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-1697-2019. Source: US FDA. Licensed CC0.

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