Device recall
Z-2253-2018: Apollo Anesthesia Machine; Cat. no. 8605310 Product Usage: Indicated as a…
FDA device recall · Class II · Draeger Medical, Inc.
Key facts
| Recall number (Z-number) | Z-2253-2018 |
|---|---|
| Recall event | 80209 |
| Product | Apollo Anesthesia Machine; Cat. no. 8605310 Product Usage: Indicated as a continuous flow anesthesia system. The Apollo may be used for manually assisted or automatic ventilation, delivery of gases and anesthetic vapor, and monitoring of oxygen and CO2 concentration, breathing pressure, respiratory… |
| Product code | BSZ |
| Recalling firm | Draeger Medical, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 12, 2020 |
| 510(k) numbers | K081447 |
| 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