Brivo MR355, NMRI system
GE Healthcare (China) Co., Ltd. · 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".…
Open FDA's page for this record- Cfres ID
- 212569
- Product res number
- Z-1240-2025
- Event date initiated
- 2025-01-31
- Event date posted
- 2025-02-28
- Recall status
- Open, Classified
- Res event number
- 96311
- Product code
- LNH
- Product description
- Brivo MR355, NMRI system
- Firm FEI number
- 3008284470
- Recalling firm
- GE Healthcare (China) Co., Ltd.
- Address 1
- 1F-5F BLD 1, No.1 Tongji South Road, Beijing Economic-Technological Development Area 1f-5f economic-technological development area bld 1 no.1 tongji south road
- City
- Beijing
- Country
- China
- Additional info contact
- GE HealthCare Service 800-4371171
- Root cause description
- Software design
- Product quantity
- 22
- Distribution pattern
- Domestic US distribution nationwide. International distribution worldwide.
- Code info
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)
- Reason for recall
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.
- Action
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.
- K numbers
- K123417
- Harmonized identifiers (openFDA)
- Device name
- System, Nuclear Magnetic Resonance Imaging
- Medical specialty description
- Radiology
- Regulation number
- 892.1000
- Device class
- 2
- K number
- K924154, K193215, K143345, K945875, K883648, K153740, K202014, K252239, K932344, K091166, K140956, K213693, K935369, K921098, K181370, K974530, K990153, K911975, K250236, K914114, K071925, K052172, K073425, K041695, K223875, K043290, K982932, K910715, K970990, K103411, K920199, K901980, K193282, K211037, K962892, K233673, K900286, K010057, K133848, K113145 +1,070 more
- PMA number
- P830074, P860010, P840007, P830076, P830053, P860062, P830051, P840063, P850043, P830052, P830081
- Registration number
- 3014635027, 3018094310, 3015223550, 3018423337, 3010326005, 1650907, 3010703925, 3003768277, 3029521953, 3014310698, 3017375271, 3014232555, 3009154005, 3033333119, 3010398867, 2247992, 3023385454, 3006369484, 3002808157, 3010009632, 1054713, 3006015847, 3011657336, 3026047529, 3008284470, 3009196578, 3013343065, 3009755250, 3031503890, 3042177665, 3013679558, 3018004899, 3009714754, 3011015597, 3006239787, 3026391023, 3004977335, 2126677, 3019844073, 3004526608 +110 more
- FEI number
- 3014635027, 3018094310, 3005214683, 3015223550, 3018423337, 3010326005, 3010703925, 3029521953, 3014310698, 3017375271, 3014232555, 3009154005, 1000571342, 3033333119, 3010398867, 3003377038, 3023385454, 3006369484, 3002808157, 3010009632, 3002808382, 3006015847, 3011657336, 3026047529, 3008284470, 3009196578, 3013343065, 1937223, 3009755250, 3031503890, 3042177665, 3013679558, 3018004899, 3009714754, 3011015597, 1000138054, 3006239787, 3026391023, 3004977335, 2126677 +110 more