Reported Mar 5, 2025 · Ongoing
Brivo MR355, NMRI system
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?
- Brivo MR355, NMRI system
- Lot codes and dates
- Brivo MR355 (No UDI) System IDs(Updated 12/29/25 - Additional System ID 83027805544513) (Updated 1/28/26 -
08242701009608242702004608242704012608242707007608242707007708242707017008242710024508242712015108242718003008242721014708242721014808242722002508242722004508242723006008242724006008242731010408562700580856270059MRR10200MRR9920RU1063MR03RU8902MR01
- Additional System IDs82427220047 82427240055 82427070163 82427060068 82427140137 82427010122 82427280018) (Updated 2/19/26: Additional System ID EG1736MR02)
- Brivo MR355 (No UDI) System IDs
- Amount recalled
- 22
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.
Want the full recall guide?
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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