Recall Z-1645-2018— Deerfield Imaging, Inc.

Name: FDA recall Z-1645-2018
Creator: U.S. Food and Drug Administration
Published: 2018-04-04

Class II · Terminated

Class II FDA medical device recall by Deerfield Imaging, Inc., initiated 2018-04-04, terminated 2020-07-22. It names one FDA 510(k) clearance: K133692. 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: 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..

Recalling firm: Deerfield Imaging, Inc.
Classification: Class II
Status: Terminated
Initiated: 2018-04-04
Terminated: 2020-07-22
Firm location: Minnetonka, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K133692 — IMRI 1.5T AND IMRI 3T SImris, Inc.·cleared 2014-02-10

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.