Quick Facts at a Glance
- Recall Date
- December 8, 2025
- Hazard Level
- HIGH
- Brand
- IMRIS Imaging
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- IMRIS Imaging
- Product type
- Head Fixation Device
- Model numbers
- 119695-000, 119629-000, 119630-000, 113803-000, 113803-600, 113802-000, 113802-600
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
December 8, 2025
Reported by FDA DEVICE
January 14, 2026
RecallRadar source check
January 21, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
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.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact IMRIS Imaging Inc or your healthcare provider for instructions. Notification method: Letter
About This Product
The HFD100 Head Fixation Device is used in surgical settings to stabilize a patient's head during imaging or surgical procedures. It is crucial for ensuring precision and safety during operations.
Why This Is Dangerous
The device's torque screw can crack or separate, compromising the fixation of the patient's head, which may lead to serious surgical risks.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall affects healthcare providers who rely on this device for surgeries, posing potential delays and the need for alternative stabilization methods.
Practical Guidance
How to identify if yours is affected
- Check the model number against the recalled models.
- Look for any visible signs of wear or damage on the torque screw.
- Verify the serial number against the provided list of affected serial numbers.
Where to find product info
The model and serial numbers can typically be found on the device label or in the user manual.
What timeline to expect
Expect a refund or replacement processing time of approximately 4-6 weeks.
If the manufacturer is unresponsive
- Document your communication attempts with the manufacturer.
- Contact the FDA to report unresponsiveness.
- Consider filing a complaint with your local consumer protection agency.
How to prevent similar issues
- When purchasing medical devices, ensure they have been thoroughly tested and approved by regulatory bodies.
- Check for any active recalls before purchasing or using medical devices.
- Maintain regular equipment checks to ensure safety and functionality.
Documentation advice
Keep records of all correspondence with the manufacturer, including emails and letters regarding the recall.
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Product Details
Affected models include HFD100 with catalog numbers 119695-000, 119629-000, 119630-000, 113803-000, 113803-600, 113802-000, and 113802-600. The device was distributed worldwide, including the US, Canada, and Japan.
Key Facts
- Recall date: December 8, 2025
- Quantity recalled: 122 units
- Hazard classification: Class II
- Risk level: High
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