Brand Name: HFD100 Product Name: Head Fixation Device HFD100… — Class II medical device recall Z-1034-2026
Ongoing recall by IMRIS Imaging Inc, reported 2026-01-14, distributed nationwide. Torque screw may crack or separate. If used, an affected screw could lead to inadequate head stabilization, co
| Recall number | Z-1034-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | IMRIS Imaging Inc, Chaska, MN, United States |
| Recall initiated | 2025-12-08 |
| Classified | 2026-01-08 |
| Reported by FDA | 2026-01-14 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, CH, CN, JP, QA, SE |
| Quantity | 122 |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 00857534006011, 00857534006592, 00857534006608, 00857534006615 |
| Serial numbers | 10002391, 10002403, 10002486, 10002695, 10002715, 10002968, 10002969, 10003048, 10003407, 10003546, 10003793, 10003794, 10003796, 10003811, 10003903, 10003906, 10003936, 10003937, 10003985, 10003987, 10003999, 10004026, 10004195, 10004215, 10004216 and 97 more |
| Model numbers | 113802-000, 113802-600, 113803-000, 113803-600, 119629-000, 119630-000, 119695-000 |
Product
Brand Name: HFD100 Product Name: Head Fixation Device HFD100 Model/Catalog Number: 119695-000, 119629-000, 119630-000, 113803-000, 113803-600, 113802-000, 113802-600 Software Version: Not Applicable Product Description: The 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. Component: Not a component.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1034-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.