Deerfield Imaging, Inc. recalls IMRIS IMRI 1.5T AND 3T S System Product Usage: The IMRIS intraoperative MRI systems are traditional MRI systems that ha…

Recall date

April 4, 2018

Source

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

Recall number

Z-1645-2018

FDA classification

Class II

Brand / firm

Deerfield Imaging, Inc.

Sold / distributed

Worldwide Distribution - US Nationwide in the states of OH, FL, NH, TX, Sweden, Canada

Why it was recalled

The DC power to the IFOSS collision detector control panel at your facility is being adversely affected by the magnetic field. Our investigation shows the magnetic field is causing the IFOSS control panel to malfunction.

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 IMRI 1.5T AND 3T S System Product Usage: The IMRIS intraoperative MRI systems are traditional MRI systems that have been suspended on an overhead rail system. and is designated to operative inside an RF shielded room to facilitate intraoperative and multi room use.