FDA recall, , Moderate risk
Micromed S.p.A. Natus SD LTM 64 PLUS EEG Amplifier/recorder
The SD LTM 64 PLUS EEG amplifier may show a 1-second delay between channels, potentially leading to misinterpretation of results.
Summary by Recall Canary from the FDA notice
What happened
Micromed S.p.A. of Mogliano Veneto, Italy, is recalling the SD LTM 64 Plus, an EEG Amplifier/recorder, after Natus became 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. The recall affects 207 units and was initiated on May 4, 2026.
The product was distributed worldwide, including US Nationwide distribution in the states of FL, PA. The recall was added to the FDA's Enforcement Report and classified on June 5, 2026, and in FDA's weekly enforcement report on June 17, 2026.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Match the list below, then check the codes the FDA notice also names.
A UDI-DI is the device identifier printed with the barcode on the device label.
SD LTM 64 Plus
- UDI-DI
- 8033928120897
From the FDA notice
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 details
- Company began the recall
- Sold in
Worldwide - US Nationwide distribution in the states of Florida, Pennsylvania.
- Company
- Micromed S.p.A.Mogliano Veneto, Italy
- Hazard
- Software defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98924
- Recall number
- Z-2353-2026
- Quantity recalled
- 207 units
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
