Reported Jun 17, 2026 · Ongoing

SD LTM 64 PLUS, EEG Amplifier/recorder, Model/Catalog Number: SD LTM 64 PLUS, Software Version: firmware 2021.02,…

Micromed S.p.A.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Micromed S.p.A. · Via Giotto 2 · Mogliano Veneto, N/A · N/A

Is this the product you have?

  • SD LTM 64 PLUS, EEG Amplifier/recorder
  • Model/Catalog NumberSD LTM 64 PLUS
  • Software Version
    • firmware 2021.02
    • 2022.01 or 2022.02
Lot codes and dates
  • UDI-DI8033928120897
  • 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
Amount recalled
207 units

Where it was sold

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:19 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.