Class II — Potential Health Hazard

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

Varian High Energy Clinacs Recalled by Varian Medical Systems, Inc. Oncology Systems Due to Under certain conditions, photon beams in High Energy...

Date: May 31, 2011
Company: Varian Medical Systems, Inc. Oncology Systems
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 Varian Medical Systems, Inc. Oncology Systems directly.

Affected Products

Varian High Energy Clinacs, High Energy Accelerator, Radiation Treatment System, Model Numbers: H14, H27, H29, HCX. Product Usage: The Varian High Energy Accelerator is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.

Quantity: 3943 units

Why Was This Recalled?

Under certain conditions, photon beams in High Energy Clinacs may experience a gradual change in beam symmetry, potentially reaching an asymmetry of up to about 7% before interlock occurs. At maximum asymmetry, this may result in no more than about 3.5% dose deviation from expected at any point in the beam, and may result in minor injury to the patient or slightly decreased local disease control.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Varian Medical Systems, Inc. Oncology Systems

Varian Medical Systems, Inc. Oncology Systems has 9 total recalls tracked by RecallDetector.

Related Recalls

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