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Deerfield Imaging, Inc. recalls IMRIS IMRI 1.5T AND 3T S System Product Usage: The IMRIS intraoperative MRI systems are traditional MRI systems that
Recalled May 16, 2018 · FDA recall Z-1645-2018 · Deerfield Imaging
Hazard
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. · FDA Class II
Units
10 units
Sold at
Worldwide Distribution - US Nationwide in the states of OH, FL, NH, TX, Sweden, Canada
Description
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.
Product
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.
Manufacturer(s)
Deerfield Imaging, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →