Device recall
Z-0151-2016: HAMILTON-G5 Ventilator with software versions between V2.00 and V2.31…
FDA device recall · Class I · Hamilton Medical, Inc.
Key facts
| Recall number (Z-number) | Z-0151-2016 |
|---|---|
| Recall event | 72319 |
| Product | HAMILTON-G5 Ventilator with software versions between V2.00 and V2.31. Anesthesiology: The HAMILTON-G5 ventilator is designed for 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 I |
| Status | Terminated |
| Termination date | Aug 24, 2017 |
| 510(k) numbers | 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