Device recall
Z-1351-2023: Outset Tablo Model Numbers (REF): PN-0006000 PN-0007001 Tablo is a next…
FDA device recall · Class II · Outset Medical, Inc.
Key facts
| Recall number (Z-number) | Z-1351-2023 |
|---|---|
| Recall event | 91844 |
| Product | Outset Tablo Model Numbers (REF): PN-0006000 PN-0007001 Tablo is a next generation, self-contained hemodialysis system (Hemodialysis System or System), intended for acute, home and chronic dialysis therapy with or without ultrafiltration, in an acute or chronic care facility. |
| Product code | FIP |
| Recalling firm | Outset Medical, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K190793, K211370 |
| FEI number | 3010355846 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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