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Deerfield Imaging, Inc. recalls IMRIS MR/X-ray head fixation device, Model HFD200
Recalled October 30, 2019 · FDA recall Z-0163-2020 · Deerfield Imaging
Hazard
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. · FDA Class II
Units
3 units
Sold at
TN, NH, FL
Description
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.
Product
IMRIS MR/X-ray head fixation device, Model HFD200
Manufacturer(s)
Deerfield Imaging, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →