IMRIS MR/X-ray head fixation device — Class II medical device recall Z-0163-2020
Terminated recall by Deerfield Imaging, Inc., reported 2019-10-30, distributed in FL, NH, TN. Breaking of the HFD200 Drive Knob force indicator due to over-torqueing of the drive knob beyond the maximum a
| Recall number | Z-0163-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Deerfield Imaging, Inc., Minnetonka, MN, United States |
| Recall initiated | 2019-06-26 |
| Classified | 2019-10-18 |
| Reported by FDA | 2019-10-30 |
| Terminated | 2020-10-29 |
| Distributed | FL, NH, TN |
| Quantity | 3 units |
| Serial numbers | 10002351, 10002448, 10002481, 10003305, 10004247, 10005723 |
| Model numbers | HFD200 |
Product
IMRIS MR/X-ray head fixation device, Model HFD200
Reason for recall
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.
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-0163-2020. 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.