GE Healthcare (China) Co., Ltd. recalls Optima MR360, NMRI system

Recall date

January 31, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1241-2025

FDA classification

Class II

Brand / firm

GE Healthcare (China) Co., Ltd.

Sold / distributed

Domestic US distribution nationwide. International distribution worldwide.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Optima MR360, NMRI system