Recall Z-2353-2026— Micromed S.p.A.

Name: FDA recall Z-2353-2026
Creator: U.S. Food and Drug Administration
Published: 2026-05-04

Class II · Ongoing

Class II FDA medical device recall by Micromed S.p.A., initiated 2026-05-04. It names one FDA 510(k) clearance: K171384. 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. Reason: 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..

Recalling firm: Micromed S.p.A.
Classification: Class II
Status: Ongoing
Initiated: 2026-05-04
Firm location: Mogliano Veneto, N/A, Italy

510(k) clearances named in this recall

1 on FDA's record

K171384 — Micromed BRAIN QUICK systemMicromed S.P.A.·cleared 2018-02-01

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

SD LTM 64 PLUS, EEG Amplifier/recorder, Model/Catalog Number: SD LTM 64 PLUS, Software Version: firmware 2021.02, 2022.01 or 2022.02

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.