Reported Jun 17, 2026 · Ongoing
SD LTM 64 PLUS, EEG Amplifier/recorder, Model/Catalog Number: SD LTM 64 PLUS, Software Version: firmware 2021.02,…
Micromed S.p.A.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Micromed S.p.A. · Via Giotto 2 · Mogliano Veneto, N/A · N/A
Is this the product you have?
- SD LTM 64 PLUS, EEG Amplifier/recorder
- Model/Catalog NumberSD LTM 64 PLUS
- Software Version
firmware 2021.022022.01 or 2022.02
- Lot codes and dates
- UDI-DI8033928120897
- Lot Code
Model No SD LTM 64 PLUSUDI-DI 8033928120897Serial Numbers BAA-0051/01-19BAA-0069/02-19BAA-0070/02-19BAA-0071/02-19BAA-0082/02-19BAA-0083/02-19BAA-0084/02-19BAA-0085/02-19BAA-0086/02-19BAA-0087/02-19BAA-0088/02-19BAA-0089/02-19BAA-0090/02-19BAA-0091/02-19BAA-0092/02-19BAA-0093/02-19BAA-0095/02-19BAA-0096/02-19BAA-0098/02-19BAA-0104/02-19BAA-0105/02-19BAA-0106/02-19BAA-0107/02-19BAA-0108/02-19BAA-0109/02-19BAA-0110/02-19BAA-0111/02-19BAA-0112/02-19BAA-0113/02-19BAA-0115/02-19BAA-0116/02-19BAA-0117/02-19BAA-0118/02-19BAA-0119/02-19BAA-0121/02-19BAA-0122/02-19BAA-0142/03-19BAA-0155/03-20BAA-0156/03-20BAA-0191/04-20BAA-0192/04-20BAA-0193/04-20BAA-0194/04-20BAA-0286/04-21BAA-0287/04-21BAA-0288/04-21BAA-0289/04-21BAA-0329/04-22
- Amount recalled
- 207 units
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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