Micromed S.p.A.: 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 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.

Tags

FDA recall, medical device, class 2, Neurology, Software Design Change, Open, Classified

Related exam domains

CISSP 3: Security Architecture and Engineering; CISSP 8: Software Development Security

Source record id

Z-2353-2026

First seen by InfoSec Signals

9/23/2026

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