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 Radiosurgery Systems Recalled by Accuray Incorporated Due to Accuray has become aware of a potential safety...

Date: December 6, 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 Radiosurgery Systems, models: G3, G4, VSI. Radiology: 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: 115 affected devices.

Why Was This Recalled?

Accuray has become aware of a potential safety issue involving the possibility of electric shock during maintenance activities from the lon Pump HV Power Supply at the back of the modulator cabinet. This issue is limited to certain G3, G4, and VSI models of the CyberKnife¿ Robotic Radiosurgery System.

Where Was This Sold?

This product was distributed to 27 states: AZ, CA, CT, FL, IN, IA, KS, LA, MD, MA, MN, MS, MO, MT, NJ, NY, NC, OH, OK, PA, TN, TX, VA, WA, WV, WI, DC

Affected (27 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