Micromed recalls SD LTM 64 PLUS EEG amplifiers with firmware 2021.02-2022.02 that may show 1-second delay between 64-channel modules, potentially causing misinterpreted brainwave data in rare cases.
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.
Micromed is recalling EEG amplifiers that may show a 1-second delay between 64-channel modules when using specific firmware versions. This could lead to misinterpreted brainwave results in rare situations, though serious injury is not a risk.
The EEG amplifier may display a fixed 1-second delay between 64-channel modules when running specific firmware versions. This delay can cause misinterpretation of brainwave data in rare cases when multiple amplifiers are used together in a multi-module SEEG configuration.
Users of the SD LTM 64 PLUS EEG amplifier/recorder with firmware versions 2021.02, 2022.01, or 2022.02 are most at risk if they use multiple amplifiers in a 128- or 256-channel configuration.
Check for the model number SD LTM 64 PLUS and firmware versions 2021.02, 2022.01, or 2022.02. The serial numbers listed in the recall include BAA-0051/01-19 through BAA-0119/02-19 and others.
Verify the firmware version on your device; if it's 2021.02, 2022.01, or 2022.02, it may be affected.
No, the recall is for potential misinterpretation of brainwave results in rare cases, not a risk of serious injury.
Check for the model number SD LTM 64 PLUS and firmware versions 2021.02, 2022.01, or 2022.02. The serial numbers listed in the recall include specific patterns like BAA-0051/01-19 through BAA-0119/02-19.
The recall does not require immediate action, but you should check your device's firmware version and serial number to determine if it's affected.
We’ve drafted a message you can send Micromed to request your refund or repair — edit it as you like.
Subject: Recall Z-2353-2026 — Micromed Micromed Hello, I own a Micromed that is covered by recall Z-2353-2026 from Micromed. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
