Device recall
Z-0126-2008: Viasys Healthcare NicoletOne ICU Monitor, Modular Neurodiagnostic System…
FDA device recall · Class III · Nicolet Biomedical Div of Viasys Healthcare
Key facts
| Recall number (Z-number) | Z-0126-2008 |
|---|---|
| Recall event | 45328 |
| Product | Viasys Healthcare NicoletOne ICU Monitor, Modular Neurodiagnostic System (containing Axiomtek Panel PC computer system), released and installed between December 2004 and March 2007 (Axiomtek Panel PC Model Number: 2147-671) VIASYS NeuroCare Part Numbers: 842-673800, 842-673900, 982A0421 and… |
| 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 | K021185 |
| 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