HFD100 Head Fixation Device Recall: Torque Screw May Crack or Separate
IMRIS Imaging recalls HFD100 Head Fixation Devices with model numbers 119695-000, 119629-000, 119630-000. Torque screws may crack or separate, risking inadequate head stabilization during surgery.
Use caution until it’s fixed
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.
Contact the company
What happened, in plain English
IMRIS Imaging recalls HFD100 Head Fixation Devices with specific model numbers. The torque screws could crack or separate, leading to unstable head fixation during surgery and potential patient injury. Read more at govinfonow.com/recall/50514-hfd100-head-fixation-device-recall-torque-screw-may-crack-or.
Source Summary by GovInfoNow · govinfonow.com/recall/50514-hfd100-head-fixation-device-recall-torque-screw-may-crack-or · Updated August 17, 2026 · FDA enforcement record: FDA #Z-1034-2026
Cite this page
“HFD100 Head Fixation Device Recall: Torque Screw May Crack or Separate.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/50514-hfd100-head-fixation-device-recall-torque-screw-may-crack-or. Based on FDA recall #Z-1034-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1034-2026%22&limit=1).
Why it’s dangerous
The torque screw in the device may crack or separate during use. This could cause inadequate head stabilization, compromising surgical precision and potentially leading to patient injury.
Who’s affected
Surgical teams using the HFD100 Head Fixation Device for neurosurgery are most at risk. Patients undergoing procedures requiring precise head stabilization may be affected.
How to tell if you have this one
Check for model numbers 119695-000, 119629-000, 119630-000, or 113803-000, 113803-600, 113802-000, 113802-600 on the device. The device is used in neurosurgery for head fixation during imaging procedures.
- Brand
HFD100- Category
Medical device
What to do — step by step
Check Device Model Numbers
Identify the model numbers on the device to confirm if it is affected.
Contact Manufacturer for Guidance
Reach out to IMRIS Imaging for specific instructions on how to address the issue.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Worldwide distribution - US Nationwide and the countries of Canada, Sweden, Switzerland, Japan, Australia, Qatar, and China.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 37 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1034-2026 (December 8, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1034-2026 to see it in context.
- Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.