SD LTM 64 PLUS, EEG Amplifier/recorder, Model/Catalog… recallZ-2353-2026 · Micromed S.p.A. · initiated May 4, 2026

Open, Classified

Is my device affected?

Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
If yours is listed, follow the instructions from Micromed S.p.A. or your healthcare provider. The company's action is summarized under what the company is doing.
Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

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.

FDA root cause category: Software Design Change

What the company is doing

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].

Recall details

Recall number: Z-2353-2026
Status: Open, Classified
Initiated by the company: May 4, 2026
Posted by the FDA: Jun 5, 2026
Recalling firm: Micromed S.p.A.
Quantity: 207 units
Product code: GWQ
FDA submissions: K171384
Distribution: Worldwide - US Nationwide distribution in the states of FL, PA.

Product description

SD 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 (models, lots, serial numbers)

Show the full code information (1k characters)

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

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Micromed SD LTM 64 PLUS
Micromed SPA · Standard Polysomnograph With Electroencephalograph
1 recall0 reports

Sources and updates

Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.

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