Device recall
Z-1584-2025: Brand Name: Cerene Cryotherapy Device Product Name: DEVICE, THERMAL ABLATION…
FDA device recall · Class II · Channel Medsystems, Inc.
Key facts
| Recall number (Z-number) | Z-1584-2025 |
|---|---|
| Recall event | 96485 |
| Product | Brand Name: Cerene Cryotherapy Device Product Name: DEVICE, THERMAL ABLATION, ENDOMETRIAL Model/Catalog Number: FGS-7000 Product Description: The Cerene Cryotherapy Device is an endometrial ablation device that uses nitrous oxide (N2O) to freeze and ablate the endometrium to reduce future menstrual… |
| Product code | MNB |
| Recalling firm | Channel Medsystems, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| PMA numbers | P180032 |
| FEI number | 3012018285 |
At a glance
- None Linked 510(k)s
- 1–9 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