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FDAJanuary 31, 2025device

SIGNA MR380, NMRI system, Non-US Only

Official recall recorded by the U.S. Food & Drug Administration.

The 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.

What to do

FDA enforcement status: Ongoing

Brands named

ge healthcare china

UPCs

00195278361257

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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