The Recall Desk
HighFDA (Devices)·Z-2353-2026·Announced 2026-06-17

Natus SD LTM 64 PLUS EEG recorders may shift traces one second

SD LTM 64 PLUS EEG amplifier/recorders are being recalled because traces from different amplifiers in a multi-amplifier configuration may be displayed with a one-second shift.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall with a stated risk of misinterpretation of EEG results, a risk of harm with no injuries reported in the source.

Plain-English summary

The SD LTM 64 PLUS EEG amplifier/recorder from Micromed S.p.A., firmware versions 2021.02, 2022.01 and 2022.02, UDI-DI 8033928120897, is being recalled. The action covers 207 units, identified by the serial numbers in the recall notice.

Natus has become aware of two complaints related to the SD LTM 64 PLUS where 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 one second between the 64-channel blocks. According to the manufacturer, in rare circumstances a fixed one-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. The FDA classified the action as Class II.

Distribution was worldwide, including within the United States in Florida and Pennsylvania. The recorders are installed in healthcare facilities rather than sold to consumers.

Facilities should identify affected units using the UDI-DI, firmware version and serial numbers in the recall notice and follow the instructions issued by the manufacturer.

The recalled product

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
Manufacturer
Micromed S.p.A.
Category
Medical Device — EEG recorder
Hazard
Affected units
207

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 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

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

Related recalls

Same hazard · firmware defect

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