Device recall
Z-0813-2022: Outset Tablo Console Model Number: PN-0003000 Model Number: PN-0006000
FDA device recall · Class II · Outset Medical, Inc.
Key facts
| Recall number (Z-number) | Z-0813-2022 |
|---|---|
| Recall event | 89616 |
| Product | Outset Tablo Console Model Number: PN-0003000 Model Number: PN-0006000 |
| Product code | KDI |
| Recalling firm | Outset Medical, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K190793, K200741 |
| FEI number | 3010355846 |
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