Device recall
Z-1638-2016: Ascom Mobile Monitoring Gateway (versions 4.1.1 and 4.2.0) and Ascom Unite…
FDA device recall · Class II · Ascom US, INC.
Key facts
| Recall number (Z-number) | Z-1638-2016 |
|---|---|
| Recall event | 73578 |
| Product | Ascom Mobile Monitoring Gateway (versions 4.1.1 and 4.2.0) and Ascom Unite Connect for Nurse Call (version 2.2.0). |
| Product code | MSX |
| Recalling firm | Ascom US, INC. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 13, 2017 |
| 510(k) numbers | K111215 |
| FEI number | 3008855170 |
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