Use cautionMedical device recall · FDA · Published February 17, 2022
Deerfield Imaging HFD100 Head Fixation Component Recall: Risk of Unnoticed Movement During
Deerfield Imaging recalls a table adapter component for IMRIS HFD100 head fixation devices. The split block clamp may deflect after force application, risking unnoticed movement during surgery and extended anesthesia time.
Reports have been received that after normal or routine lateral forces are applied to the head fixation device, the split block clamp may deflect (rotationally around the axis) and not return to within acceptable distance from its prior position after the force is removed. In order to reduce deflection at the table mount location, users have tightened the hand knob screw to a degree that it is then difficult to untighten it later in the clinical workflow. Rotational movement at the table attachment point could result in HFD movement going unnoticed, which could result in a situation where surgical or medical intervention is necessary, a situation where navigation needs to be reestablished, or a situation resulting in extended time under anesthesia for the patient. It may also be difficult to loosen the mount clamp component after use, potentially leading to ergonomic injury or a workaround during equipment teardown.
Take action
Contact the company
📍Recalling firmDeerfield Imaging, Inc.5101 Shady Oak Rd S · Minnetonka, MN 55343-4100
“Deerfield Imaging HFD100 Head Fixation Component Recall: Risk of Unnoticed Movement During.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61136-deerfield-imaging-hfd100-head-fixation-component-recall-risk-of-unnoticed. Based on FDA recall #Z-0934-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0934-2022%22&limit=1).
The FDA announced on Feb. 17, 2022, that Deerfield Imaging, Inc. is recalling the Trumpf Mount Clamp Assembly (part #118704-000) due to a hazard where rotational movement may go unnoticed during use. This defect could necessitate surgical intervention or extended anesthesia for patients.
How to tell if you have it
Brand: Deerfield Imaging
Product: Trumpf Mount Clamp Assembly (table adapter component)
Part #: 118704-000
Component of IMRIS HFD100 head fixation device, models #119629-000 and #119630-000
Sold in AL, FL, GA, MA, MN, NC, NY, OH, TX, Sweden, and Switzerland
The hazard
According to the FDA, reports indicate that lateral forces may cause the split block clamp to deflect and not return to its prior position. This rotational movement at the table attachment point could result in HFD movement going unnoticed, potentially leading to necessary surgical intervention, reestablished navigation, or extended anesthesia time for the patient.
Context
GovInfoNow's records show Deerfield Imaging, Inc. has had 8 other recalls since Feb. 20, 2018. Other recent recalls of similar products include HFD100 Head Fixation Device Recall: Torque Screw May Crack or Separate (Dec. 8, 2025), IMRIS ORT300 Operating Room Table Recall: Risk of Patient Injury from Unintended Movement (Aug. 6, 2026), and Olympus HX-400U-30 Ligating Device Recall: Risk of Unintentional Loop Fixation (Oct. 30, 2025).
How to tell if you have this one
Check for the part number 118704-000 on the IMRIS HFD100 head fixation device. The affected models have specific serial numbers listed in the recall notice.
Brand
Deerfield Imaging
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Component Status
Inspect the split block clamp for signs of deflection after applying lateral force. If it does not return to its original position, it may be affected.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 9 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide distribution - US Nationwide distribution in the states of AL, FL, GA, MA, MN, NC, NY, OH, and TX. The countries of Sweden and Switzerland.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Florida, Georgia, Massachusetts, Minnesota, New York, North Carolina, Ohio, Texas.
Recall timeline
FDA terminated this recall 2.2 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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.
Official source: FDA Recall #Z-0934-2022 (February 17, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0934-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.