Device recall
Z-2057-2015: Hamilton-G5 Ventilators with software versions V2.40/2.41 Catalog numbers for…
FDA device recall · Class II · Hamilton Medical, Inc.
Key facts
| Recall number (Z-number) | Z-2057-2015 |
|---|---|
| Recall event | 71234 |
| Product | Hamilton-G5 Ventilators with software versions V2.40/2.41 Catalog numbers for G5: 159001 and 159002. Software: 159700.. Intensive care ventilation of adult and pediatric patients and optionally infant and neonatal patients. |
| Product code | CBK |
| Recalling firm | Hamilton Medical, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 23, 2015 |
| 510(k) numbers | K103803, K131774 |
| FEI number | 2937708 |
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