Device recall
Z-1874-2019: HAMILTON-G5, with software versions less than or equal to 2.60 The…
FDA device recall · Class I · Hamilton Medical AG
Key facts
| Recall number (Z-number) | Z-1874-2019 |
|---|---|
| Recall event | 82328 |
| Product | HAMILTON-G5, with software versions less than or equal to 2.60 The HAMILTON-G5/S1 ventilators are designed for intensive care ventilation of adult and pediatric patients, and optionally infant and neonatal patients. The device is intended for use in the hospital and institutional environment where… |
| Product code | CBK |
| Recalling firm | Hamilton Medical AG |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Jun 3, 2024 |
| 510(k) numbers | K081521, K103803, K131774 |
| 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