Medical Device Recall: Optima MR360, NMRI system
GE Healthcare (China) Co., Ltd. · January 31, 2025
Reason for Recall
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.
Distribution
Domestic US distribution nationwide. International distribution worldwide.
States Affected
NATIONWIDE
Quantity Affected
33
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1241-2025
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.