FDA recall Z-1645-2018

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.

Reason for recall

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.

Distribution

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

Key facts

Status

Terminated

Initiation date

2018-04-04

Report date

2018-05-16

Termination date

2020-07-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Minnetonka, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1645-2018