Nicolet EEG Wireless Amplifier 32/64 Channel — Class II medical device recall Z-0946-2013
Terminated recall by Natus Neurology Incorporated, reported 2013-03-20, distributed nationwide. Natus Neurology Incorporated is recalling the Nicolet EEG Wireless Amplifier which may overheat and become unc
| Recall number | Z-0946-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Natus Neurology Incorporated, Middleton, WI, United States |
| Recall initiated | 2013-02-27 |
| Classified | 2013-03-13 |
| Reported by FDA | 2013-03-20 |
| Terminated | 2014-04-25 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BH, BR, CA, CH, DE, DK, EG, ES, GB, HK, ID, IE, IN, IT, JP, KR, KW, MX, MY, NL, RO, RU, SG, TH, TR, TW, UY, VN |
| Reason classes | device malfunction |
| Model numbers | 515-015400 |
Product
Nicolet EEG Wireless Amplifier 32/64 Channel. Catalog/Part Numbers : 515-015400 for the 32 channel amplifier and 515-015500 for the 64 channel amplifier. Product Usage: The Nicolet Wireless EEG Amplifier is intended to be used as a front end amplifier to acquire, store, and transmit electrophysiological signals in a wired or wireless mode for the Nicolet Neurodiagnostic system.
Reason for recall
Natus Neurology Incorporated is recalling the Nicolet EEG Wireless Amplifier which may overheat and become uncomfortable to touch around the area of the on/off button. The overheating may result in discomfort ranging from too hot up to the potential for a burn.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0946-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
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.