Medical Device Recall: SD LTM 64 PLUS, EEG Amplifier/recorder, Model/Catalog Number: SD LTM 64 PLUS, Software Version: firmware 2021.02, 2022.01 or 2022.02
Micromed S.p.A. · May 4, 2026
Reason for Recall
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 between the 64channels blocks. In rare circumstances, a fixed 1-second temporal delay may appear between two 64-channel modules with firmware 2021.02, 2022.01 or 2022.02 in a multi-module SEEG configuration, potentially leading to misinterpretation of results.
Distribution
Worldwide - US Nationwide distribution in the states of FL, PA.
States Affected
NATIONWIDE
Quantity Affected
207 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-2353-2026
Status: ongoing
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