Device recall
Z-1141-2026: Brand Name: EDAN Product Name: Fetal & Maternal Monitor Model/Catalog Number…
FDA device recall · Class II · Edan Diagnostics
Key facts
| Recall number (Z-number) | Z-1141-2026 |
|---|---|
| Recall event | 97879 |
| Product | Brand Name: EDAN Product Name: Fetal & Maternal Monitor Model/Catalog Number: F6, F9, F6 Express, F9 Express Product Description: The devices are bedside fetal and maternal monitors, which are used to monitor the physiological parameters of pregnant women including the fetus from 28 weeks gestation… |
| Product code | HGM |
| Recalling firm | Edan Diagnostics |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K150901, K173042 |
| 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