Recall Z-1034-2026 ยท HBL Holder, Head, Neurosurgical (Skull Clamp)
IMRIS Imaging Inc
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 diffe
| Date | Jan 8, 2026 (initiated Dec 8, 2025) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Device Design |
| Action | FIrm notified consignees via an Urgent Medical Device Recall letter on December 8, 2025. Service will contact customers to replace the torque screw components. Until the torque screws are replaced, customers should follow these mitigations: " Ensure the patient s head is supported during pin penetration: serious patient injury may result from improper head and neck support during pin penetration of the skull for head placement. " If a crack develops during advancement or retraction, please discontinue use and release the skull clamp halves through activating the base locking knob. Please noti |
| Quantity | 122 |
| Distribution | Worldwide distribution - US Nationwide and the countries of Canada, Sweden, Switzerland, Japan, Australia, Qatar, and China. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K103493 | HEAD FIATION DEVICE (HFD 100) Imris, Inc., Mar 11, 2011 |