Device recall
Z-1144-2026: Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: iM3s…
FDA device recall · Class II · Edan Diagnostics
Key facts
| Recall number (Z-number) | Z-1144-2026 |
|---|---|
| Recall event | 97879 |
| Product | Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: iM3s, iM3As, iM3Bs, iHM3s Product Description: The iM3s series vital signs monitors including iM3s/iM3As/iM3Bs/iHM3s are intended to be used for measuring, storing, reviewing of, and generating prompts for multiple… |
| Product code | MWI |
| Recalling firm | Edan Diagnostics |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K202892, K233038 |
| FEI number | 3009499478 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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