Device recall
Z-1146-2026: Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: elite V5…
FDA device recall · Class II · Edan Diagnostics
Key facts
| Recall number (Z-number) | Z-1146-2026 |
|---|---|
| Recall event | 97879 |
| Product | Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: elite V5, elite V6, elite V8 Product Description: V series Patient Monitor including elite V5, elite V6 and elite V8 which can perform long-time continuous monitoring of multiple physiological parameters. Also, it is capable of… |
| Product code | MHX |
| Recalling firm | Edan Diagnostics |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K160981 |
| FEI number | 3009499478 |
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