Brand Name: HFD100 Product Name: Head Fixation Device HFD100 Model/Catalog Number: 119695-000, 119629-000, 119630-000, 1
FDA device recall Z-1034-2026 · posted 2026-01-08 · Open, Classified
Recall details
- Recalling firm
- IMRIS Imaging Inc
- 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.
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Open, Classified
- Product code
- HBL
- Quantity affected
- 122
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Sweden, Switzerland, Japan, Australia, Qatar, and China.
- Date initiated
- 2025-12-08
- Date posted
- 2026-01-08
- Location
- Chaska, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HEAD FIATION DEVICE (HFD 100) (K103493) | Imris, Inc. | 2011-03-11 |