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

[pending] SD LTM 64 PLUS, EEG Amplifier/recorder, Model/Catalog Number: SD LTM 64 PLUS, Software Version: firm

Pending LLM rewrite. Source: FDA_DEVICE Z-2353-2026.

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: Pending LLM scoring against the rubric.

Plain-English summary

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.

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 — Devices

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.

Related recalls

Same category