Optima MR360, NMRI system
For certain MR systems, a scan can be resumed following a Power Monitor trip when the "6-minute average SAR" is above the limit indicated on the "SAR Display". The user interface may incorrectly enable a scan to proceed earlier than intended. If resumed by the operator, such a scan can result in potential excessive tissue heating, especially if the patient is in contact with a conductive material or has an implant.
Domestic US distribution nationwide. International distribution worldwide.
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1241-2025