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U.S. Department of Health and Human Services

Class 2 Device Recall SD LTM 64 PLUS

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 Class 2 Device Recall SD LTM 64 PLUSsee related information
Date Initiated by FirmMay 04, 2026
Date PostedJune 05, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2353-2026
Recall Event ID 98924
510(K)NumberK171384 
Product Classification Full-montage Standard Electroencephalograph - Product Code GWQ
ProductSD LTM 64 PLUS, EEG Amplifier/recorder, Model/Catalog Number: SD LTM 64 PLUS, Software Version: firmware 2021.02, 2022.01 or 2022.02
Code Information 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
FEI Number 3005994236
Recalling Firm/
Manufacturer		 Micromed S.p.A.
Via Giotto 2
Mogliano Veneto Italy
Manufacturer 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.
FDA Determined
Cause 2		Software Design Change
ActionAn 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. " Please complete the enclosed form and return to FCA@Natus.com. If you have affected devices with firmware 2021.02, 2022.01 or 2022.02, you will receive detailed instructions from FCA@Natus.com. " Adverse reactions or quality problems experienced with the use of the part should be reported to Natus and the FDA's MedWatch Adverse Event Reporting program either online, by regular mail, or by fax. " Complete and submit the report Online at www.fda.gov/medwatch/report.htm. " Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178. " In the event you have affected product, once you provide the completed Customer Reply Form that is listed below to FCA@natus.com, Technical Service will be in contact with you to arrange for local servicing or return the device(s) for service. RESOLUTION: " Issue is resolved by updating the product firmware to version 2023.01 or later. " Natus has identified the root cause of this issue and has implemented corrective actions to prevent future recurrence. If you have any questions regarding this notice, please contact FCA@Natus.com.
Quantity in Commerce207 units
DistributionWorldwide - US Nationwide distribution in the states of FL, PA.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = GWQ
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