Micromed SD LTM 64 PLUS EEG amplifier recalled for timing delay in multi-module configurations
Micromed SD LTM 64 PLUS EEG amplifier recalled for timing delay
When using two or four amplifiers together in certain configurations, the SD LTM 64 PLUS may display a 1-second timing delay between channel blocks. This delay could cause doctors to misinterpret EEG test results. The issue affects devices running specific firmware versions.
- Check if your device serial number matches the affected list provided by the manufacturer
- Contact Micromed or your equipment supplier for instructions on checking and updating your firmware
- Do not rely on multi-module configurations until you have confirmed your device is not affected or has been corrected
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2353-2026Don't want to check this manually?
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