BEUDAMED
    FDA Enforcement Class II Ongoing

    Brivo MR355, NMRI system

    Recall: Z-1240-2025 · Reported March 5, 2025

    Enforcement

    Recall Number
    Z-1240-2025
    Event ID
    96311
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    GE Healthcare (China) Co., Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 5, 2025
    Initiation Date
    January 31, 2025
    Classification Date
    February 27, 2025
    Address
    1F-5F BLD 1, No.1 Tongji South Road, Beijing Economic-Technological Development Area, N/A, Beijing, N/A, N/A, China

    Description

    Brivo MR355, NMRI system

    Reason

    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.

    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)

    Distribution

    Domestic US distribution nationwide. International distribution worldwide.

    Quantity

    22