Class II — Blackrock Microsystems, LLC
| Recalling firm | Blackrock Microsystems |
|---|---|
| Registered facility | Blackrock Microsystems (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| 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. |
| Product | Patient Cable. Part Numbers: 4460, 6735. Sterile within Chipboard Boxes within corrugated cartons. 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) |
| Quantity | 120 total cables |
| Distribution | Worldwide Distribution - US Nationwide and Canada, |
| Initiated | 2016-08-10 |
| Classified | 2016-09-08 |
| Terminated | 2017-08-21 |
| Recall number | Z-2764-2016 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Blackrock Microsystems, LLC (Z-2764-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/74893/
Alerts for Blackrock Microsystems
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.