Reported Mar 5, 2025 · Ongoing
Optima MR360, 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?
- Optima MR360, NMRI system
- Lot codes and dates
- A. UDI-DI 00840682113762 System ID 0910274038 B. No UDI-DI System IDs(Update 12/29/25 - Additional System IDs 83027809699615, LV4026MR01) (Update 1/28/26 - Additional System ID 82427190104)
0824270401340824270401850824270600430824270700880824270700930824270700990824271001740824271001780824271001970824271201400824271400950824272200460824272700410824273100880824273100920830272887903100856270061AE1373MR01DZ1339MR03FI1432MR01H4678MR04MRR9282MRR9877PL2059MR01PL2433MR01RU3338MR03SA1056MR03SA2191MR04SA2253MR01SA2352MR01TN1008MR01TN1241MR0134352MRS01
- A. UDI-DI 00840682113762 System ID 0910274038 B. No UDI-DI System IDs
- Amount recalled
- 33
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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