FDA Medical devices recall ·
Brivo MR355, NMRI system recall
- Recall number
- Z-1240-2025
- Date
- (initiated January 31, 2025)
- Company / brand
- GE Healthcare (China) Co., Ltd.
1F-5F BLD 1, No.1 Tongji South Road, Beijing Economic-Technological Development Area, Beijing, N/A, China - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 22
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Brivo MR355, NMRI system
Why was it 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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot 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)
Distribution
Domestic US distribution nationwide. International distribution worldwide.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1240-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.