Reported Mar 5, 2025 · Ongoing
SIGNA MR380, NMRI system, Non-US Only
GE Healthcare (China) Co., Ltd.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: GE Healthcare (China) Co., Ltd. · 1F-5F BLD 1, No.1 Tongji South Road, Beijing Economic-Technological Development Area · Beijing, N/A · N/A
Is this the product you have?
- SIGNA MR380, NMRI system, Non-US Only
- Lot codes and dates
- SIGNA MR380 UDI-DI 00195278361257 System IDsB. No UDI-DI System IDs
172 of 172 codes
082427020110082427020116082427040288082427040293082427040296082427040309082427070258082427070264082427070267082427070268082427070272082427070275082427070284082427070286082427070287082427070288082427070289082427070292082427070293082427070294082427070295082427070303082427070304082427070305082427070306082427070307082427070310082427070311082427070317082427070320082427070337082427090417082427090428082427090431082427090439082427090462082427090468082427100424082427100427082427100428082427100438082427100443082427100452082427100453082427100465082427100467082427100468082427100470082427100472082427100488082427100498082427110124082427110127082427110131082427110134082427110136082427110137082427110139082427110158082427120299
(Updated 2/19/26 - addl systems 82427150143 82427210255)082427020125082427040334082427090500082427120298082427130182082427130183082427130185082427140237082427140311082427140313082427180080082427210254082427230209082427270080082427270084082427290062
- SIGNA MR380 UDI-DI 00195278361257 System IDs
- Amount recalled
- 188
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
- Nationwide
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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