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.

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.

FIrm notified consignees via an Urgent Medical Device Recall letter on December 8, 2025. Service will contact customers to replace the torque screw components. Until the torque screws are replaced, customers should follow these mitigations: " Ensure the patient s head is supported during pin penetration: serious patient injury may result from improper head and neck support during pin penetration of the skull for head placement. " If a crack develops during advancement or retraction, please discontinue use and release the skull clamp halves through activating the base locking knob. Please notify IMRIS. " Prior to each device use, closely inspect the torque screw component for any signs of wear, cracking, or damage along the exterior threads. " Handle the torque screw with care during assembly, disassembly, cleaning and storage between uses; if the torque screw is inadvertently dropped or impacted by another object, immediately discontinue use and notify IMRIS. " Ensure the instructions in the Operator Manual for proper HFD100 Head Fixation Device assembly and use are followed to produce rigid fixation. " Please distribute this notice to any personnel responsible for handling, cleaning, or storing HFD100 Head Fixation Device components and report any undesired device operation or feedback.