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 P

Recall Summary The HFD100 Head Fixation Device (multiple model numbers listed) is being recalled because torque screws in the device may crack or separate. If this happens during use, the patient's head may not be adequately stabilized during surgery, which could affect surgical precision, delay the procedure, require switching to a different fixation method, or potentially injure the patient.

Recalling firm

IMPRIS Imaging Inc

Product

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...

Reason

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.

Classification

Class II

Category

consumer product recall

Country

United States

Agency

FDA-DEVICES

Recall date

2025-12-08

Status

Open, Classified

Official recall notice from FDA-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/677e4989-29ce-468d-8290-73b6ef1db866