Nicolet¿ Ambulatory EEG — Class II medical device recall Z-2568-2018
Terminated recall by Natus Neurology Inc, reported 2018-08-08, distributed in AR, AZ, CA, CO, DC, FL, GA, ID…. Potential to be able to import an ambulatory exam for a patient for which the exam was not started.
| Recall number | Z-2568-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Natus Neurology Inc, Middleton, WI, United States |
| Recall initiated | 2018-02-01 |
| Classified | 2018-07-28 |
| Reported by FDA | 2018-08-08 |
| Terminated | 2022-10-21 |
| Distributed | AR, AZ, CA, CO, DC, FL, GA, ID, IL, IN, MA, ME, MI, MO, NC, ND, NJ, NV, NY, PA, TN, TX, VA, WA, WI |
| Countries outside the US | AE, AU, BE, CN, DE, HK, IL, IT, JO, KW, RU, SI, TN, VN |
| Quantity | 171 units |
| UPC / GTIN / UDI-DI | 00382830043670 |
| Serial numbers | 140859, 150923, 80218, LBR06028, LBR06051, LBR06094, LBR06095, LBR06101, LBR06133, LBR120757, LBR120759, LBR120771, MBR090299, MBR090303, MBR090306, MBR090308, MBR090313, MBR090317, MBR090318, MBR090321, MBR090324, MBR090326, MBR090327, MBR090329, MBR090330 and 143 more |
Product
Nicolet¿ Ambulatory EEG
Reason for recall
Potential to be able to import an ambulatory exam for a patient for which the exam was not started.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.