Recall Z-2353-2026
- Recall number
- Z-2353-2026
- Event number
- 98924
- Firm FEI
- 3005994236
- Product code
- GWQ
- Status
- Open, Classified
- Initiated
- 2026-05-04
- Posted
- 2026-06-05
- Root cause
- Software Design Change
- 510(k) numbers
- K171384, K221959, K071109, K791150, K212788, K113117, K781041, K791233, K162595, K791234, K910279, K964280, K010088, K903004, K854030, K033399, K180269, K181466, K231366, K970942, K051825, K002570, K010089, K870815, K010997, K081741, K191492, K863124, K921138, K904763
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#
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.