Z-2353-2026Class II

SD LTM 64 PLUS, EEG Amplifier/recorder, Model/Catalog Number: SD LTM 64 PLUS, Software Version: firmware...

Name: Z-2353-2026 SD LTM 64 PLUS, EEG Amplifier/recorder, Model/Catalog Number: SD LTM 64 PLUS, Software Version: firmware...
Creator: Micromed S.p.A.
Published: 2026-05-04
License: https://open.fda.gov/license/

MicroMed, LLC / initiated 2026-05-04 / Open, Classified / root cause: software

FDA source

Micromed S.p.A. began a recall of SD LTM 64 PLUS, EEG Amplifier/recorder, Model/Catalog Number: SD LTM 64 PLUS, Software Version: firmware 2021.02, 2022.01 or 2022.02 on 2026-05-04. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-2353-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-05-04
Posted: 2026-06-05
Recalling firm: MicroMed, LLC
Product: SD LTM 64 PLUS, EEG Amplifier/recorder, Model/Catalog Number: SD LTM 64 PLUS, Software Version: firmware 2021.02, 2022.01 or 2022.02
Product code: GWQ Full-Montage Standard Electroencephalograph
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.
Root cause tag: software
FDA 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. " Please complete the enclosed form and return to [email protected]. If you have affected devices with firmware 2021.02, 2022.01 or 2022.02, you will receive detailed instructions from [email protected]. " 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 [email protected], 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 [email protected].
Quantity in commerce: 207 units
Distribution: Worldwide - US Nationwide distribution in the states of FL, PA.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2353-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2353-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-06-17	2026-06-05

Product code GWQ

K171384Class IIMicromed BRAIN QUICK systemMicromed S.P.A. / cleared 2018-02-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)