Device recall
Z-1221-2019: Maquet Servo-I Ventilator System -EDI CATHETER PHT Free 6Fr/49cm 5/pkg Product…
FDA device recall · Class III · GETINGE US SALES LLC
Key facts
| Recall number (Z-number) | Z-1221-2019 |
|---|---|
| Recall event | 82533 |
| Product | Maquet Servo-I Ventilator System -EDI CATHETER PHT Free 6Fr/49cm 5/pkg Product Code/REF Number: 6685775 Product Usage: The Edi Catheter is a single-use naso-gastric feeding tube with an electrode array of ten electrodes. The Edi Catheter is intended for: - Detecting diaphragmatic electrical… |
| Product code | PIF |
| Recalling firm | GETINGE US SALES LLC |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Apr 8, 2020 |
| 510(k) numbers | K153688 |
| FEI number | 3012092534 |
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