Class 2 Device Recall HFD100 Head Fixation Device

• Date Initiated by Firm: December 08, 2025
• Date Posted: January 08, 2026
• Recall Status: Open, Classified
• Recall Number: Z-1034-2026
• Recall Event ID: 98132
• 510(K)Number: K103493
• Product Classification: Holder, head, neurosurgical (skull clamp) - Product Code HBL
• 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 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.
• Code Information: Affected UDI-DI: 00857534006011 00857534006592 00857534006608 00857534006615 Affected serial numbers: 10006206 10005998 10003999 10004026 10003796 10003811 10006629 10006630 10007514 10007515 10002486 10003048 10004215 10004216 10003794 10004231 10012064 10012310 10012311 10010990 10011142 10007914 10007971 10002391 10002969 10009132 10010058 10011570 10005134 10005711 10009569 10009878 10010057 10003903 10003906 10003546 10006187 10012838 10010639 10010666 10011925 10006692 10007246 10011463 10005092 10007237 10007509 10008416 10003407 10003793 10004195 10004975 10004993 10005136 10010381 10007906 10013179 10007510 10007511 10007245 10004449 10004961 10005849 10005851 10010747 10006730 10011187 10011307 10009593 10010003 10008073 10008354 10011546 10011571 10006207 10012127 10006631 10007777 10006411 10004466 10005445 10011645 10009015 10004291 10003985 10003987 10006204 10006205 10007235 10007236 10006412 10004775 10004323 10004942 10003936 10003937 10007130 10002695 10007126 10007128 10009228 10009210 10009583 10005480 10005481 10012839 10008645 10008670 10006693 10006694 10004317 10002403 10004673 10004671 10010572 10006212 10006203 10002968 10002715 10011186 10011265 10010059
• FEI Number: 3010326005
• Recalling Firm/ Manufacturer: IMRIS Imaging Inc; 1230 Chaska Creek Way Ste 100; Chaska MN 55318-2707
• For Additional Information Contact: 763-203-6300
• Manufacturer Reason for Recall: 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.
• FDA Determined Cause: Device Design
• Action: 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.
• Quantity in Commerce: 122
• Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Sweden, Switzerland, Japan, Australia, Qatar, and China.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = HBL