Device recall
Z-0712-2008: CES Ultra, Cranial Electrotherapy Stimulator, Serial Numbers: 1000 through 3999…
FDA device recall · Class II · Neuro-Fitness LLC
Key facts
| Recall number (Z-number) | Z-0712-2008 |
|---|---|
| Recall event | 45503 |
| Product | CES Ultra, Cranial Electrotherapy Stimulator, Serial Numbers: 1000 through 3999, Manufactured by Arco Electronics Limited, Distributed by Neuro-Fitness LLC, Fall City, Washington 98024 |
| Product code | JXK |
| Recalling firm | Neuro-Fitness LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 21, 2011 |
| 510(k) numbers | K062284 |
| FEI number | 3005026995 |
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