Device recall
Z-0092-2021: Servo-i Ventilator, Part No. 6487800, UDI Code 07325710000823 - Product Usage…
FDA device recall · Class II · Getinge Group Logistics America, LLC
Key facts
| Recall number (Z-number) | Z-0092-2021 |
|---|---|
| Recall event | 86548 |
| Product | Servo-i Ventilator, Part No. 6487800, UDI Code 07325710000823 - Product Usage: intended for general and critical ventilator care, and it can be used for low end to high end intensive care, in different configurations. It supports a variety of breathing modes and can be used for Neonates, Pediatric… |
| Product code | CBK |
| Recalling firm | Getinge Group Logistics America, LLC |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K123149 |
| FEI number | 3025504317 |
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