FDA recall, , Moderate risk
IMRIS HFD100 Head Fixation Device
The Head Fixation Device HFD100 has a torque screw that may crack or separate, risking patient injury.
Summary by Recall Canary from the FDA notice
What happened
IMRIS Imaging Inc of Chaska, Minnesota began a recall of the Head Fixation Device HFD100 on December 8, 2025, because the 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.
The FDA added the recall to its Enforcement Report and classified it on January 8, 2026, with distribution worldwide, including the US and Canada, Sweden, Switzerland, Japan, Australia, Qatar, and China.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its model number is listed.
Head Fixation Device HFD100
- Model number
- 119695-000
- 119629-000
- 119630-000
- 113803-000
- 113803-600
- 113802-000
- 113802-600
Recall details
- Company began the recall
- Sold in
Worldwide distribution - US Nationwide and the countries of Canada, Sweden, Switzerland, Japan, Australia, Qatar, and China.
- Company
- IMRIS Imaging IncChaska, Minnesota
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98132
- Recall number
- Z-1034-2026
All recalls from IMRIS Imaging Inc
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
