Device recall
Z-1151-2026: Brand Name: EDAN Product Name: Central Monitoring System Model/Catalog Number…
FDA device recall · Class II · Edan Diagnostics
Key facts
| Recall number (Z-number) | Z-1151-2026 |
|---|---|
| Recall event | 97879 |
| Product | Brand Name: EDAN Product Name: Central Monitoring System Model/Catalog Number: MFM-CNS, MFM-CNS Lite Product Description: The MFM-CNS and MFM-CNS Lite are clinical data managing software applications. Both applications manage clinical data of fetal monitoring and uterine activity, and the MFM-CNS… |
| Product code | HGM |
| Recalling firm | Edan Diagnostics |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K171178 |
| 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