Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

CyberKnife VSI Recalled by Accuray Incorporated Due to There is an unintended drop of a secondary...

Date: April 10, 2018
Company: Accuray Incorporated
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Accuray Incorporated directly.

Affected Products

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

Quantity: 43 units

Why Was This Recalled?

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.

Where Was This Sold?

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

About Accuray Incorporated

Accuray Incorporated has 20 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report