Device recall
Z-0380-2007: NicoletOne version 5.20 software (also known as NicoletOne Version 5.2 Software)…
FDA device recall · Class III · Nicolet Biomedical Div of Viasys Healthcare
Key facts
| Recall number (Z-number) | Z-0380-2007 |
|---|---|
| Recall event | 36241 |
| Product | NicoletOne version 5.20 software (also known as NicoletOne Version 5.2 Software) used with the NicoletOne LTM, Sleep, nEEG, vEEG and ICU monitoring Systems. |
| Product code | GWQ |
| Recalling firm | Nicolet Biomedical Div of Viasys Healthcare |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Dec 10, 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