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Blackrock NeuroPort Biopotential Signal Processing System
BLACKROCK MICROSYSTEMS, LLC · Model 7.0.3 · UDI-DI 00814901020308
1
510(k) clearances
5
Adverse events
4
Recalls
25
Facilities
Description
NeuroPort Central Suite
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2016-08-10 | Blackrock Microsystems, LLC | Blackrock Microsystems, LLC announces a voluntary field action for the Blackrock NeuroPort Biopotential Signal Processing System because the Neural Signal Amplifier and the Patient |
| 2016-08-10 | Blackrock Microsystems, LLC | Blackrock Microsystems, LLC announces a voluntary field action for the Blackrock NeuroPort Biopotential Signal Processing System because the Neural Signal Amplifier and the Patient |
| 2013-02-27 | Natus Neurology Incorporated | 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 overhea |
| 2010-03-26 | I2s Micro Implantable Systems Llc | Component of cranial array may not allow sufficient tightening to maintain inserter position. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.