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 Head Frame - Model number HHF -ALL Head Frame Recalled by Varian Medical Systems, Inc. Due to Varian Medical Systems has received a report that...

Date: September 13, 2016
Company: Varian Medical Systems, Inc.
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. directly.

Affected Products

Varian Head Frame - Model number HHF -ALL Head Frame Posts (PN1008016 ) and Post Kits (PN1008016). The Varian Head Frame System is for use with a computed tomography scanner to perform imaging for treatment planning and a charged particle accelerator to perform immobilization of the treatment target for stereotactic radiosurgery or radiotherapy treatments on cranial lesions, tumors and conditions where radiation treatment is indicated.

Quantity: 75 devices

Why Was This Recalled?

Varian Medical Systems has received a report that a user was able to easily rotate the head frame posts when attached to the mounting cam on the metal head ring. There was no report of serious injury due to this issue

Where Was This Sold?

US Distribution and Internationally to 1 site in Canada, India and Morocco

About Varian Medical Systems, Inc.

Varian Medical Systems, Inc. has 19 total recalls tracked by RecallDetector.

Related Recalls

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