Deerfield Imaging, Inc. recalls IMRIS MR/X-ray head fixation device, Model HFD200

Recall date

June 26, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0163-2020

FDA classification

Class II

Brand / firm

Deerfield Imaging, Inc.

Sold / distributed

TN, NH, FL

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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