SD LTM 64 PLUS, EEG Amplifier/recorder, Model/Catalog Number: SD LTM 64 PLUS, Software Version: firmware 2021.02, 2022.01 or 2022.02
Recall
- Recall Number
- Z-2353-2026
- Event Number
- 98924
- FEI Number
- 3005994236
- Product Code
- GWQ
- Status
- Open, Classified
- Root Cause
- Software Design Change
- Initiated
- May 4, 2026
- Posted
- June 5, 2026
- Address
- Micromed S.p.A. Via Giotto 2 Mogliano Veneto Italy
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
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.
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].
Worldwide - US Nationwide distribution in the states of FL, PA.
207 units