Brivo MR355, NMRI system recallZ-1240-2025 · GE Healthcare (China) Co., Ltd. · initiated Jan 31, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from GE Healthcare (China) Co., Ltd. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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.
FDA root cause category: Software design
What the company is doing
On January 31, 2025, the firm notified customers through Urgent Medical Device Correction letters. Customers were provided with instructions for continued use of their MR systems. All potential users should be made aware of this safety notification and recommended actions. If you have any questions or concerns regarding this notification, please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative.
Recall details
- Recall number
- Z-1240-2025
- Status
- Open, Classified
- Initiated by the company
- Jan 31, 2025
- Posted by the FDA
- Feb 28, 2025
- Recalling firm
- GE Healthcare (China) Co., Ltd.
- Quantity
- 22
- Product code
- LNH
- FDA submissions
- K123417
- Distribution
- Domestic US distribution nationwide. International distribution worldwide.
Product description
Brivo MR355, NMRI system
Code information (models, lots, serial numbers)
Brivo MR355 (No UDI) System IDs 082427010096 082427020046 082427040126 082427070076 082427070077 082427070170 082427100245 082427120151 082427180030 082427210147 082427210148 082427220025 082427220045 082427230060 082427240060 082427310104 0856270058 0856270059 MRR10200 MRR9920 RU1063MR03 RU8902MR01 (Updated 12/29/25 - Additional System ID 83027805544513) (Updated 1/28/26 - Additional System IDs: 82427220047 82427240055 82427070163 82427060068 82427140137 82427010122 82427280018) (Updated 2/19/26: Additional System ID EG1736MR02)
Other devices under the same FDA submission
2 devices cleared under K123417 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- NA 1.5T EXPRESS COIL - 16E HEAD NECK ARRAYGe Healthcare(Tianjin) Company Limited · System, nuclear magnetic resonance imaging1 recall0 reports
- NA 1.5T EXPRESS COIL - 9E ANTERIOR ARRAYGe Healthcare(Tianjin) Company Limited · System, nuclear magnetic resonance imaging1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 96311).
- Z-1239-2025 · Open, ClassifiedSIGNA Creator, SIGNA Explorer, NMRI systems
- Z-1241-2025 · Open, ClassifiedOptima MR360, NMRI system
- Z-1242-2025 · Open, ClassifiedSIGNA MR355, SIGNA MR360, NMRI system
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page