Device recall
Z-2763-2016: Neural Signal Amplifier. Part Numbers: 4208, 5703, 5749, 5748, 5747. Product…
FDA device recall · Class II · Blackrock Microsystems, LLC
Key facts
| Recall number (Z-number) | Z-2763-2016 |
|---|---|
| Recall event | 74893 |
| 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… |
| Product code | GWL |
| Recalling firm | Blackrock Microsystems, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 21, 2017 |
| 510(k) numbers | K090957 |
| FEI number | 3007323246 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database