Device recall
Z-1485-2024: Tablo Hemodialysis System, REF: PN-0003000, PN-0006000 and PN-0007001
FDA device recall · Class I · Outset Medical, Inc.
Key facts
| Recall number (Z-number) | Z-1485-2024 |
|---|---|
| Recall event | 94224 |
| Product | Tablo Hemodialysis System, REF: PN-0003000, PN-0006000 and PN-0007001 |
| Product code | KDI |
| Recalling firm | Outset Medical, Inc. |
| Recall class | Class I |
| Status | Open, Classified |
| 510(k) numbers | K233335 |
| 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