Device recall
Z-1178-2019: Olympus Diego Elite Console MDCONS 100
FDA device recall · Class II · Gyrus ACMI, Inc.
Key facts
| Recall number (Z-number) | Z-1178-2019 |
|---|---|
| Recall event | 82451 |
| Product | Olympus Diego Elite Console MDCONS 100 |
| Product code | GEI |
| Recalling firm | Gyrus ACMI, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 8, 2020 |
| 510(k) numbers | K123429 |
| FEI number | 1037007 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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