Device recall
Z-0675-2020: Cognision, Subject Kit (Clinical Grade), Model 3000- containing Hydro Dot brand…
FDA device recall · Class II · Neuronetrix Solutions, LLC dba Cognision
Key facts
| Recall number (Z-number) | Z-0675-2020 |
|---|---|
| Recall event | 84324 |
| Product | Cognision, Subject Kit (Clinical Grade), Model 3000- containing Hydro Dot brand Wave Prep cups-electroconductive cream for use with external electrodes. Order No. D5000, Part No. PN-1720 - Product Usage: An electroconductive cream for use with external electrodes to reduce the impedance of the… |
| Product code | KOY |
| Recalling firm | Neuronetrix Solutions, LLC dba Cognision |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 26, 2020 |
| 510(k) numbers | K970694 |
| FEI number | 3011184129 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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