Reported Jan 14, 2026 · Ongoing
Brand Name: HFD100 Product Name: Head Fixation Device HFD100 Model/Catalog Number: 119695-000, 119629-000, 119630-000,…
IMRIS Imaging Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: IMRIS Imaging Inc · 1230 Chaska Creek Way Ste 100 · Chaska, MN · 55318-2707
Is this the product you have?
- Brand NameHFD100
- Product NameHead Fixation
- Device HFD100 Model/Catalog Number
119695-000119629-000119630-000113803-000113803-600113802-000113802-600
- Software VersionNot
- Applicable Product DescriptionThe 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
- ComponentNot a component
- Lot codes and dates
- Affected UDI-DI00857534006011 00857534006592 00857534006608 00857534006615
- Affected serial numbers
122 of 122 codes
100062061000599810003999100040261000379610003811100066291000663010007514100075151000248610003048100042151000421610003794100042311001206410012310100123111001099010011142100079141000797110002391100029691000913210010058100115701000513410005711100095691000987810010057100039031000390610003546100061871001283810010639100106661001192510006692100072461001146310005092100072371000750910008416100034071000379310004195100049751000499310005136100103811000790610013179100075101000751110007245
- Amount recalled
- 122
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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