GE Healthcare (China) Co., Ltd. recalls Brivo MR355, NMRI system
Recalled Product
Brivo MR355, NMRI system
Hazard / Issue
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.
Issued by
FDA
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