FDA Device recall Z-0163-2020
IMRIS MR/X-ray head fixation device, Model HFD200
- FDA Device
- Class II
- terminated
- Published 2019-10-30
On 2019-10-30 the FDA classified a Class II recall of IMRIS MR/X-ray head fixation device, Model HFD200 by Deerfield Imaging, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0163-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-06-26 |
| Published | 2019-10-30 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Deerfield Imaging |
| Distribution | FL, NH, TN |
Product
IMRIS MR/X-ray head fixation device, Model HFD200
Reason
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.
Identifiers
| code_info | HFD Serial Number Drive Knob Serial Number 10002481 10003305 10002351 10005723 10004247 10002448 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
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FDA Device · Class II · 2020-01-08 · Deerfield Imaging
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0163-2020%22
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