FDA-Device2018-05-16Class II
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.
Deerfield Imaging, Inc.
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.
Sold states
Worldwide Distribution - US Nationwide in the states of OH, FL, NH, TX, Sweden, Canada
Affected count
10 units
Manufactured in
5101 Shady Oak Rd S, N/A, Minnetonka, MN, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1645-2018Don't want to check this manually?
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