Device recall
Z-2250-2018: Fabius GS Premium Anesthesia Machine; Cat. no. 8607000 Product Usage: Inhalation…
FDA device recall · Class II · Draeger Medical, Inc.
Key facts
| Recall number (Z-number) | Z-2250-2018 |
|---|---|
| Recall event | 80209 |
| Product | Fabius GS Premium Anesthesia Machine; Cat. no. 8607000 Product Usage: Inhalation anesthesia machines for use in operating, induction and recovery rooms. They may be used with O2, N2O, and AIR supplied by a medical gas pipeline system or by externally mounted gas cylinders. Fabius series machines are… |
| Product code | BSZ |
| Recalling firm | Draeger Medical, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 12, 2020 |
| 510(k) numbers | K042419 |
| FEI number | 2517967 |
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