SD LTM 64 PLUS recall (Micromed S.p.A.)
Medical deviceClass IIOngoing
Summary: Micromed S.p.A. is recalling 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.
What is being recalled
SD LTM 64 PLUS, EEG Amplifier/recorder, Model/Catalog Number: SD LTM 64 PLUS, Software Version: firmware 2021.02, 2022.01 or 2022.02
Why
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.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
Worldwide - US Nationwide distribution in the states of FL, PA. (states named: Florida, Pennsylvania)
How to tell if yours is affected
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, 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
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-2353-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | May 4, 2026 |
| Reported | June 17, 2026 |
| Company | Micromed S.p.A. |
| Company location | Mogliano Veneto, N/A, Italy |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 207 units |
More recalls from Micromed S.p.A. · all medical device recalls · recalls from May 2026