Device recall
Z-0737-2012: NicVue Software version 2.9.2 and 3.0.1. Medical Device Data System (MDDS)…
FDA device recall · Class II · CareFusion 209 Inc.
Key facts
| Recall number (Z-number) | Z-0737-2012 |
|---|---|
| Recall event | 60797 |
| Product | NicVue Software version 2.9.2 and 3.0.1. Medical Device Data System (MDDS) Intended use: The NicVue software is intended to be the patient database for various Nicolet applications. The NicVue software is intended to aid the hospital in tracking patient data from collection to review to archive. The… |
| Product code | OUG |
| Recalling firm | CareFusion 209 Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 11, 2012 |
| FEI number | 3010611950 |
At a glance
- None 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