SD LTM 64 PLUS, EEG Amplifier/recorder, Model/Catalog Number: SD LTM 64 PLUS, Software Version: firmware 2021.02, 2022.01 or 2022.02
Class II
- Recalling firm
- Micromed S.p.A.
- 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 pattern
- Worldwide - US Nationwide distribution in the states of FL, PA.
- State
- N/A
- Status
- Ongoing
- Recall number
- Z-2353-2026
- Recall initiated
- May 4, 2026
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