Use cautionMedical device recall · FDA · Published June 26, 2019
Deerfield Imaging HFD200 Head Fixation Device Recall: Risk of Improper Skull Pinning
Deerfield Imaging recalls HFD200 MR/X-ray head fixation devices due to potential improper skull pinning from drive knob force indicator failure. Affected units have specific serial numbers.
Breaking of the HFD200 Drive Knob force indicator due to over-torqueing of the drive knob beyond the maximum allowable pinning force specification may result in the clinical staff unknowingly pinning the patient's skull with insufficient force; the clinical staff unknowingly pinning the patient's skull with excessive force; or the clinical staff identifying the issue and not being able to continue with the procedure.
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Contact the company
📍Recalling firmDeerfield Imaging, Inc.5101 Shady Oak Rd S · Minnetonka, MN 55343-4100
✎ GovInfoNow plain-language explainer
Deerfield Imaging is recalling its HFD200 head fixation device because the drive knob force indicator can break under over-torqueing, leading to either insufficient or excessive force on the patient's skull. This could cause injury during medical procedures if not properly monitored. Read more at govinfonow.com/recall/67581-deerfield-imaging-hfd200-head-fixation-device-recall-risk-of-improper.
“Deerfield Imaging HFD200 Head Fixation Device Recall: Risk of Improper Skull Pinning.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/67581-deerfield-imaging-hfd200-head-fixation-device-recall-risk-of-improper. Based on FDA recall #Z-0163-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0163-2020%22&limit=1).
Deerfield Imaging, Inc. voluntarily recalled its IMRIS MR/X-ray head fixation device, Model HFD200, on June 26, 2019, according to the Food and Drug Administration (FDA). The recall addresses a hazard where breaking of the drive knob force indicator may result in insufficient or excessive skull pinning force. Three units were distributed in Tennessee, New Hampshire, and Florida.
How to tell if you have it
Brand: Deerfield Imaging
Product: IMRIS MR/X-ray head fixation device
Model: HFD200
Units affected: 3
Distribution locations: TN, NH, FL
The hazard
The FDA stated that breaking of the HFD200 Drive Knob force indicator due to over-torqueing may result in clinical staff unknowingly pinning the patient's skull with insufficient or excessive force. The hazard also includes the possibility that staff identify the issue but cannot continue with the procedure.
Context
GovInfoNow's records show Deerfield Imaging, Inc. has had eight other recalls on record since Feb. 20, 2018. Other recent recalls of similar products include HFD100 Head Fixation Device Recall (Dec. 8, 2025), Olympus HX-400U-30 Ligating Device Recall (Oct. 30, 2025), and Hologic 3D Mammography Systems Recall (April 8, 2026).
How to tell if you have this one
Check for the HFD200 model with specific serial numbers: 10002481, 10003305, 10002351, 10005723, 10004247, 10002448. These units were sold with the drive knob force indicator that can fail.
Brand
Deerfield Imaging
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Device Serial Numbers
Verify if your HFD200 device has one of the listed serial numbers: 10002481, 10003305, 10002351, 10005723, 10004247, 10002448.
Where it went and when
Where it was distributed
Distributed in 3 states.
Listed by the agency
Not listed
FDA distribution: “TN, NH, FL” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Florida, New Hampshire, Tennessee.
Recall timeline
FDA terminated this recall 16 months 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-0163-2020 (June 26, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0163-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 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.