IMRIS Imaging recalls HFD100 Head Fixation Devices with model numbers 119695-000, 119629-000, 119630-000. Torque screws may crack or separate, risking inadequate head stabilization during surgery.
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.
IMRIS Imaging recalls HFD100 Head Fixation Devices with specific model numbers. The torque screws could crack or separate, leading to unstable head fixation during surgery and potential patient injury.
The torque screw in the device may crack or separate during use. This could cause inadequate head stabilization, compromising surgical precision and potentially leading to patient injury.
Surgical teams using the HFD100 Head Fixation Device for neurosurgery are most at risk. Patients undergoing procedures requiring precise head stabilization may be affected.
Check for model numbers 119695-000, 119629-000, 119630-000, or 113803-000, 113803-600, 113802-000, 113802-600 on the device. The device is used in neurosurgery for head fixation during imaging procedures.
Identify the model numbers on the device to confirm if it is affected.
Reach out to IMRIS Imaging for specific instructions on how to address the issue.
The torque screw may crack or separate, which could lead to inadequate head stabilization during surgery and potential patient injury.
Model numbers 119695-000, 119629-000, 119630-000, 113803-000, 113803-600, 113802-000, and 113802-600 are affected.
Check the device model numbers and contact IMRIS Imaging for guidance on next steps.
We’ve drafted a message you can send HFD100 to request your refund or repair — edit it as you like.
Subject: Recall Z-1034-2026 — HFD100 HFD100 Hello, I own a HFD100 that is covered by recall Z-1034-2026 from HFD100. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
