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 Robotic Recalled by Accuray Incorporated Due to The gun box mounting bracket may fail to...

Date: January 22, 2016
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 Robotic; Catalog/part number 032000 and 033000 Cosmetic cover package. Product Usage: The CyberKnife Robotic Radiosurgery System is 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.

Quantity: 226

Why Was This Recalled?

The gun box mounting bracket may fail to support the weight of the gun box when in vertical (inverted) position. If this failure occurs the gun box may become loose and could come into contact with a patient.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

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