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    FDA Recall: Unknown manufacturer, Full-Montage Standard Electroencephalograph

    Natus has become aware of two complaints related to the SD LTM 64 PLUS where the EEG traces acquired from two or four different amplifiers used in a multiple amplifier configuration (128 or 256 channels) running firmware version 2022.02 were displayed with a shift of 1 second…

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    Software Quality
    info

    Recalling firm: Unknown manufacturer

    Device class: 2

    Device name: Full-Montage Standard Electroencephalograph

    Event initiated: 2026-05-04

    FDA posted: 2026-06-05

    Recall ID: Z-2353-2026

    Product: SD LTM 64 PLUS, EEG Amplifier/recorder, Model/Catalog Number: SD LTM 64 PLUS, Software Version: firmware 2021.02, 2022.01 or 2022.02

    Reason for recall

    (not provided)

    Citations
    #gray-zone#recall
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