SD LTM 64 PLUS, EEG Amplifier/recorder, Model/Catalog Number: SD LTM 64 PLUS, Software Version: firmware 2021.02, 2022.01 or 2022.02
Micromed S.p.A.
The hazard
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. FDA Class II recall.
The remedy
Follow FDA guidance
About this recall
SD LTM 64 PLUS, EEG Amplifier/recorder, Model/Catalog Number: SD LTM 64 PLUS, Software Version: firmware 2021.02, 2022.01 or 2022.02
Affected identifiers
Check these against the label on your unit. An identifier match is how a recall is confirmed, not just suspected.
Model UDI-DI: 8033928120897Model Lot Code: Model No SD LTM 64 PLUSModel UDI-DI 8033928120897Model Serial Numbers BAA-0051/01-19Model BAA-0069/02-19Model BAA-0070/02-19Model BAA-0071/02-19Model BAA-0082/02-19Model BAA-0083/02-19Model BAA-0084/02-19Model BAA-0085/02-19Model BAA-0086/02-19Model BAA-0087/02-19Model BAA-0088/02-19Model BAA-0089/02-19Model BAA-0090/02-19Model BAA-0091/02-19Model BAA-0092/02-19Model BAA-0093/02-19Model BAA-0095/02-19Model BAA-0096/02-19Model BAA-0098/02-19Model BAA-0104/02-19Model BAA-0105/02-19Model BAA-0106/02-19UPC 8033928120897Would you have heard about this one?
RapidRecall watches everything you own against every new federal recall and emails you the moment something you bought turns up. Free for your most important items.
Start monitoring freeSourced from the Food and Drug Administration’s public recall data. Always verify serial and date ranges against the official notice before acting.