Notice names this product. Micromed S.p.A’s SD LTM 64 PLUS is named in FDA Class II recall Z-2353-2026. Your particular item is not yet verified. Compare the identifiers and exclusions in the notice before deciding whether it applies. Agency-reported hazard: 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. Identifying details: UDI-DI: 8033928120897; Lot Code: Model No SD LTM 64 PLUS; UDI-DI 8033928120897; Serial Numbers BAA-0051/01-19, BAA-0069/02-19, BAA-0070/02-19, BAA-0071/02-19, BAA-0082/02-19, BAA-0083/02-19, BAA-0084/02-19, BAA-0085/02-19, BAA-0086/02-19, BAA-0087/02-19, BAA-0088/02-19, BAA-0089/02-19, BAA-0090/02-19, BAA-0091/02-19, BAA-0092/02-19, BAA-0093/02-19, BAA-0095/02-19, BAA-0096/02-19, BAA-0098/02-19, BAA-0104/02-19, BAA-0105/02-19, BAA-0106/02-19, BAA-0107/02-19, BAA-0108/02-19, BAA-0109/02-19, BAA-0110/02-19, BAA-0111/02-19, BAA-0112/02-19, BAA-0113/02-19, BAA-0115/02-19, BAA-0116/02-19, BAA-0117/02-19, BAA-0118/02-19, BAA-0119/02-19, BAA-0121/02-19, BAA-0122/02-19, BAA-0142/03-19, BAA-0155/03-20, BAA-0156/03-20, BAA-0191/04-20, BAA-0192/04-20, BAA-0193/04-20, BAA-0194/04-20, BAA-0286/04-21, BAA-0287/04-21, BAA-0288/04-21, BAA-0289/04-21, BAA-0329/04-22. Units affected: 207 units. Status: Ongoing.
This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.
SD LTM 64 PLUS, EEG Amplifier/recorder, Model/Catalog Number: SD LTM 64 PLUS, Software Version: firmware 2021.02, 2022.01 or 2022.02
Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.
If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.
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 configuratio…
Company / brand: Micromed S.p.A recalls
Affected product: SD LTM 64 PLUS recall status
Official ID Z-2353-2026 · Official record ↗
See all Micromed S.p.A recalls →
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Compiled from connected official public-domain government data. Sources last checked October 22, 2026 at 6:00 PM UTC.