FDA Device recall Z-2763-2016
Neural Signal Amplifier
- FDA Device
- Class II
- terminated
- Published 2016-09-14
On 2016-09-14 the FDA classified a Class II recall of Neural Signal Amplifier by Blackrock Microsystems, citing blackrock Microsystems, LLC announces a voluntary field action for the Blackrock NeuroPort Biopotential Signal Processing System because the Neural Signal Amplifier and the Patien….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2763-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-08-10 |
| Published | 2016-09-14 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Blackrock Microsystems |
| Distribution | US |
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
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.
Identifiers
| code_info | Part Number 4208: Serial Numbers 0014 and 0016 Only Part Number 5703: All Serial Numbers Part Number 5748: All Seria…Part Number 4208: Serial Numbers 0014 and 0016 Only Part Number 5703: All Serial Numbers Part Number 5748: All Serial Numbers Part Number 5747: All Serial Numbers |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2763-2016%22
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