Device recall
Z-2064-2016: Alaris System PC Unit Model 8015 with software versions 9.17 and 9.19; Central…
FDA device recall · Class II · CareFusion 303, Inc.
Key facts
| Recall number (Z-number) | Z-2064-2016 |
|---|---|
| Recall event | 74142 |
| Product | Alaris System PC Unit Model 8015 with software versions 9.17 and 9.19; Central programming, monitoring and power supply component for the Alaris System. |
| Product code | FRN |
| Recalling firm | CareFusion 303, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 24, 2018 |
| 510(k) numbers | K051641 |
| FEI number | 2016493 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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