FDA-Device2025-03-05Class II
SIGNA MR380, NMRI system, Non-US Only
GE Healthcare (China) Co., Ltd.
Hazard
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.
Sold states
Domestic US distribution nationwide. International distribution worldwide.
Affected count
188
Manufactured in
1F-5F BLD 1, No.1 Tongji South Road, Beijing Economic-Technological Development Area, N/A, Beijing, N/A, China
Products
SIGNA MR380, NMRI system, Non-US Only
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1243-2025Don't want to check this manually?
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