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FDAJune 26, 2019device

IMRIS MR/X-ray head fixation device, Model HFD200

Official recall recorded by the U.S. Food & Drug Administration.

The 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.

What to do

FDA enforcement status: Terminated

Brands named

deerfield imagingdeerfield

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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IMRIS MR/X-ray head fixation device, Model HFD200 — Recall Details · AllClear