Recall Z-1584-2025 ยท MNB Device, Thermal Ablation, Endometrial
Channel Medsystems, Inc.
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 bleeding. The device is intended for use by healthcare professionals who have received appropriate t
| Date | Apr 16, 2025 (initiated Mar 20, 2025) |
| Status | Open, Classified |
| Reason | Due to evaporator gasket not sealing which can cause liquid nitrous oxide to drip/leak from the bottom of the device handle during treatment or after treatment during venting of the device |
| Root cause | Under Investigation by firm |
| Action | On 03/20/2025, the firm emailed customer an "URGENT MEDICAL DEVICE CORRECTION" Letter informing them that the evaporator gasket inside the handle of the device may not seal properly, which can cause liquid nitrous oxide to drip/leak from the bottom of the device handle during treatment or after treatment during venting of the device. Customers are instructed to: 1. Check your internal inventory to determine if you have any affected devices. 2. Stop use of affected devices. 3. Vent the affected devices by following the attached instructions and then discard the devices according to your facili |
| Quantity | 281 |
| Distribution | U.S Nationwide distribution in the states of AL, AZ, CA, CO, CT, DE, FL, GA, IL, IN, KY, LA, MD, MO, NC, NY, OH, PA, PR, RI, TN, TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.