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GE Healthcare (China) Co., Ltd. recalls SIGNA MR380, NMRI system, Non-US Only
Recalled March 5, 2025 · FDA recall Z-1243-2025 · GE Healthcare (China)
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. · FDA Class II
Units
188
Sold at
Domestic US distribution nationwide. International distribution worldwide.
Description
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.
Product
SIGNA MR380, NMRI system, Non-US Only
Manufacturer(s)
GE Healthcare (China) Co., Ltd.
Made in
China
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →