Recall Z-2353-2026 ยท GWQ Full-Montage Standard Electroencephalograph
Micromed S.p.A.
SD LTM 64 PLUS, EEG Amplifier/recorder, Model/Catalog Number: SD LTM 64 PLUS, Software Version: firmware 2021.02, 2022.01 or 2022.02
| Date | Jun 5, 2026 (initiated May 4, 2026) |
| Status | Open, Classified |
| 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. |
| Root cause | Software Design Change |
| Action | An Urgent Medical Device Recall notification letter dated 4/27/26 was sent to customers. ACTION: Natus is requesting you to check your SD LTM 64 PLUS stock and identify whether the devices are currently running firmware version 2021.02, 2022.01 or 2022.02. The information is displayed on the device screen when the device is switched on if you keep the switch on button pressed. " Immediately cease use of the affected product in configurations with multiple amplifiers (i.e, systems with 128- or 256-channels) until you receive the instructions from Natus to return it or have it serviced locally. |
| Quantity | 207 units |
| Distribution | Worldwide - US Nationwide distribution in the states of FL, PA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K171384 | Micromed BRAIN QUICK system Micromed S.P.A., Feb 1, 2018 |