Full-montage Standard Electroencephalograph
Recall Summary Natus is recalling the SD LTM 64 PLUS EEG machine (a device that records brain electrical activity) with certain firmware versions because when multiple amplifier units are connected together, the brain wave recordings from different modules may display with a 1-second time shift between them. This timing misalignment could cause healthcare providers to misinterpret the test results. The affected devices were distributed worldwide and throughout the United States.
- 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
- 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.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-05-04
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Worldwide - US Nationwide distribution in the states of FL, PA.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/442c8a97-0ff8-4e6c-a4d7-7f50e2abcedf