Class II — Potential Health Hazard

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

IMRIS MR/X-ray head fixation device Recalled by Deerfield Imaging, Inc. Due to Breaking of the HFD200 Drive Knob force indicator...

Date: June 26, 2019
Company: Deerfield Imaging, 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 Deerfield Imaging, Inc. directly.

Affected Products

IMRIS MR/X-ray head fixation device, Model HFD200

Quantity: 3 units

Why Was This Recalled?

Breaking of the HFD200 Drive Knob force indicator due to over-torqueing of the drive knob beyond the maximum allowable pinning force specification may result in the clinical staff unknowingly pinning the patient's skull with insufficient force; the clinical staff unknowingly pinning the patient's skull with excessive force; or the clinical staff identifying the issue and not being able to continue with the procedure.

Where Was This Sold?

This product was distributed to 3 states: FL, NH, TN

Affected (3 states)Not affected

About Deerfield Imaging, Inc.

Deerfield Imaging, Inc. has 19 total recalls tracked by RecallDetector.

Related Recalls

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