Neural Signal Amplifier — Class II medical device recall Z-2763-2016
Terminated recall by Blackrock Microsystems, LLC, reported 2016-09-14, distributed nationwide. Blackrock Microsystems, LLC announces a voluntary field action for the Blackrock NeuroPort Biopotential Signal
| Recall number | Z-2763-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Blackrock Microsystems, LLC, Salt Lake City, UT, United States |
| Recall initiated | 2016-08-10 |
| Classified | 2016-09-08 |
| Reported by FDA | 2016-09-14 |
| Terminated | 2017-08-21 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 81 amplifiers |
| Reason classes | labeling |
| Serial numbers | 0014, 0016 |
| Model numbers | 4208, 5703, 5747, 5748, 5749 |
Product
Neural Signal Amplifier. Part Numbers: 4208, 5703, 5749, 5748, 5747. Product Usage: The Blackrock NeuroPort Biopotential Signal Processing System supports recording, processing and display of biopotential signals from user supplied electrodes. Biopotential signals include: Electrocorticography (ECoG), electroencephalography (EEG), electromyography (EMG), electrocardiography (ECG), electrooculography (EOG) and Evoked Potential (EP)
Reason for recall
Blackrock Microsystems, LLC announces a voluntary field action for the Blackrock NeuroPort Biopotential Signal Processing System because the Neural Signal Amplifier and the Patient Cable are incorrectly labeled as Type CF Applied Parts.
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-2763-2016. 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.