Device recall
Z-2328-2025: Hamilton C6 REF 160021 (ESM Board PN 10144626 UDI-DI code: 76300028PN160021ZW…
FDA device recall · Class I · Hamilton Medical AG
Key facts
| Recall number (Z-number) | Z-2328-2025 |
|---|---|
| Recall event | 97079 |
| Product | Hamilton C6 REF 160021 (ESM Board PN 10144626 UDI-DI code: 76300028PN160021ZW Hamilton C6 is a ventilator intended to provide positive pressure ventilatory support to adults and pediatrics and optionally infants and neonates. |
| Product code | CBK |
| Recalling firm | Hamilton Medical AG |
| Recall class | Class I |
| Status | Open, Classified |
| 510(k) numbers | K201658 |
| FEI number | 3014766741 |
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