SD LTM 64 PLUS EEG Amplifier Recall
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Micromed S.p.A. is recalling 207 units of the SD LTM 64 PLUS EEG Amplifier/recorder due to potential 1-second display shifts in multi-amplifier configurations.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on July 27, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, medical-devices.
What Happened
Micromed S.p.A. initiated a voluntary recall of the SD LTM 64 PLUS EEG Amplifier/recorder after reports of EEG traces displaying with a 1-second shift between 64-channel blocks in multiple amplifier setups (128 or 256 channels). The issue affects devices running firmware versions 2021.02, 2022.01, or 2022.02 and may lead to misinterpretation of results.
Which Products Are Affected
The recall covers the SD LTM 64 PLUS, EEG Amplifier/recorder, Model/Catalog Number: SD LTM 64 PLUS, with firmware versions 2021.02, 2022.01 or 2022.02. A total of 207 units are affected. UDI-DI is 8033928120897. Distribution was to the United States in the states of FL and PA. Serial numbers include BAA-0051/01-19 through BAA-0329/04-22 as listed in the recall notice. Recall number is Z-2353-2026.
What You Should Do
Consumers and facilities should follow guidance from the recalling firm regarding the affected devices.
Why This Matters
The potential temporal delay in EEG data from multi-module configurations could affect result interpretation in clinical settings.
Source
FDA recall Z-2353-2026. https://www.fda.gov
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,139 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to July 27, 2026.
Frequently Asked Questions
Common questions about this FDA recall.