Class II — Potential Health Hazard

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

Brand Name: HFD100 Product Name: Head Fixation Device HFD100 Model/Catalog Recalled by IMRIS Imaging Inc Due to Torque screw may crack or separate. If used,...

Date: December 8, 2025
Company: IMRIS Imaging Inc
Status: Ongoing
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 IMRIS Imaging Inc directly.

Affected Products

Brand Name: HFD100 Product Name: Head Fixation Device HFD100 Model/Catalog Number: 119695-000, 119629-000, 119630-000, 113803-000, 113803-600, 113802-000, 113802-600 Software Version: Not Applicable Product Description: The HFD100 Head Fixation Device provides rigid skeletal fixation within the optimal imaging envelope while introducing minimal artifacts in the acquired images. There are two different assemblies for the HFD100. The standard HFD100 is equipped with a table adapter for use with either the operating room table or the angiography table. For sites with a Hill-Rom TruSystem 7500 Hybrid Neuro MR Operating Table (ORT400), the HFD100 has a split block clamp assembly (Trumpf Mount Clamp Assembly) which connects directly to the table back section. The HFD100 system is also comprised of the linkage components to mount the skull clamp to the table adapter, and the 3-pin skull clamp. The linkage system is used to position the skull clamp in the necessary position, without colliding with the magnet bore. Component: Not a component.

Quantity: 122

Why Was This Recalled?

Torque screw may crack or separate. If used, an affected screw could lead to inadequate head stabilization, compromised surgical precision, procedural delays, requirement for alternate head fixation methods, and risk of patient injury.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About IMRIS Imaging Inc

IMRIS Imaging Inc has 1 total recall tracked by RecallDetector.

Related Recalls

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