BEUDAMED
    FDA Enforcement Class II Ongoing

    Optima MR360, NMRI system

    Recall: Z-1241-2025 · Reported March 5, 2025

    Enforcement

    Recall Number
    Z-1241-2025
    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

    Optima MR360, 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

    A. UDI-DI 00840682113762 System ID 0910274038 B. No UDI-DI System IDs 082427040134 082427040185 082427060043 082427070088 082427070093 082427070099 082427100174 082427100178 082427100197 082427120140 082427140095 082427220046 082427270041 082427310088 082427310092 083027288790310 0856270061 AE1373MR01 DZ1339MR03 FI1432MR01 H4678MR04 MRR9282 MRR9877 PL2059MR01 PL2433MR01 RU3338MR03 SA1056MR03 SA2191MR04 SA2253MR01 SA2352MR01 TN1008MR01 TN1241MR01 34352MRS01 (Update 12/29/25 - Additional System IDs 83027809699615, LV4026MR01) (Update 1/28/26 - Additional System ID 82427190104)

    Distribution

    Domestic US distribution nationwide. International distribution worldwide.

    Quantity

    33