Device recall
Z-1568-2022: Servo-air Ventilator System-The Servo-air Ventilator System is: Intended for…
FDA device recall · Class II · Getinge Usa Sales Inc
Key facts
| Recall number (Z-number) | Z-1568-2022 |
|---|---|
| Recall event | 90648 |
| Product | Servo-air Ventilator System-The Servo-air Ventilator System is: Intended for respiratory support, monitoring and treatment of pediatric and adult patients. Model Number: 6882000 (equipped with 6881999 mobile cart) |
| Product code | CBK |
| Recalling firm | Getinge Usa Sales Inc |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K192604 |
| FEI number | 3013876692 |
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