Device recall
Z-0834-2022: FORE-SIGHT ELITE Absolute Tissue Oximeter, REF: 01-06-3000, Contents: Monitor 1…
FDA device recall · Class II · Edwards Lifesciences, LLC
Key facts
| Recall number (Z-number) | Z-0834-2022 |
|---|---|
| Recall event | 89647 |
| Product | FORE-SIGHT ELITE Absolute Tissue Oximeter, REF: 01-06-3000, Contents: Monitor 1 EA., Accessory Kit 1 EA. |
| Product code | MUD |
| Recalling firm | Edwards Lifesciences, LLC |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K143675 |
| FEI number | 2015691 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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