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.
Recall
- Recall Number
- Z-1645-2018
- Event Number
- 79816
- Firm
- Deerfield Imaging, Inc.
- FEI Number
- 3010326005
- Product Code
- LNH
- Status
- Terminated
- Root Cause
- Device Design
- Initiated
- April 4, 2018
- Terminated
- July 22, 2020
- Address
- 5101 Shady Oak Rd S, Minnetonka, MN, 55343-4100
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.
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.
IMRIS sent Service bulletin T200627-B01 Rev dated March 14, 2018. - through email to all affected customers. The letter identified the affected product, the problem, and the actions required to be taken by the customer. For questions contact IMRIS Customer Support 866-475-0525.
Worldwide Distribution - US Nationwide in the states of OH, FL, NH, TX, Sweden, Canada
10 units