Device recall
Z-2795-2018: Hamilton-C1 Ventilator Unit Product Usage: The HAMILTON-C1 ventilator is…
FDA device recall · Class II · Hamilton Medical AG
Key facts
| Recall number (Z-number) | Z-2795-2018 |
|---|---|
| Recall event | 80467 |
| Product | Hamilton-C1 Ventilator Unit Product Usage: The HAMILTON-C1 ventilator is intended to provide positive pressure ventilation support to adults and pediatrics. The device is used in the in the intensive care ward, in the recovery room, and during transfer of ventilated patients within the hospital. |
| Product code | CBK |
| Recalling firm | Hamilton Medical AG |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 18, 2019 |
| 510(k) numbers | K140939 |
| FEI number | 3001421318 |
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