Micromed S.P.A. recalls SD LTM 64 PLUS

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.

SD LTM 64 PLUS, EEG Amplifier/recorder, Model/Catalog Number: SD LTM 64 PLUS, Software Version: firmware 2021.02, 2022.01 or 2022.02

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 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.

• FDA enforcement recordOfficial FDA database entry for Z-2353-2026
• FDA 510(k) clearance · K171384The device's official FDA premarket clearance record
• FDA device classification · GWQOfficial FDA classification for this device type
• CFR regulation · 21 CFR 882.1400The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Micromed S.p.A.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.