Deerfield Imaging, Inc. recalls IMRIS MR/X-ray head fixation device, Model HFD200
Recalled Product
IMRIS MR/X-ray head fixation device, Model HFD200
Hazard / Issue
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.
Issued by
FDA
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