Device recall
Z-2459-2008: NicoletOne 5.30.2 Software when used with CSeries amplifiers in Fixed Room LTM…
FDA device recall · Class II · Cardinal Health NeuroCare Division
Key facts
| Recall number (Z-number) | Z-2459-2008 |
|---|---|
| Recall event | 49350 |
| Product | NicoletOne 5.30.2 Software when used with CSeries amplifiers in Fixed Room LTM Configurations with patient room kits. The product is used for extended monitoring of EEG in a hospital setting. The system provides connection between the patient room EEG acquisition system and central control room. |
| Product code | GWQ |
| Recalling firm | Cardinal Health NeuroCare Division |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 11, 2011 |
| 510(k) numbers | K991054 |
| FEI number | 3010611950 |
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