Recall Z-1645-2018 ยท LNH System, Nuclear Magnetic Resonance Imaging
Deerfield Imaging, Inc.
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.
| Date | Apr 4, 2018 |
| Status | Terminated |
| 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. |
| Root cause | Device Design |
| Action | 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. |
| Quantity | 10 units |
| Distribution | Worldwide Distribution - US Nationwide in the states of OH, FL, NH, TX, Sweden, Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K133692 | IMRI 1.5T AND IMRI 3T S Imris, Inc., Feb 10, 2014 |