Recall Z-1889-2024 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 | May 23, 2024 (initiated May 3, 2024) |
| Status | Open, Classified |
| Reason | Error code 003 was not listed in certain rows of the Device Instructions for Use Troubleshooting section (i.e., Table 22. Summary of LCD Messages and Error Codes). |
| Root cause | Device Design |
| Action | On 05/03/2024, the firm sent an "URGENT FIELD SAFETY NOTICE" via email to customers informing them that Channel Medsystems is updating its troubleshooting instructions to further inform healthcare professionals on the safe use and troubleshooting of the Cerene Device. the IFU has been updated to clarify that error code 003 can occur at any time (not only before, but also during, or after cryoablation treatment) and to instruct the user to continue to follow the correctly displayed Cerene Device LCD message and corresponding IFU troubleshooting instructions specifically, Uterus Partially Tre |
| Quantity | 1772 |
| Distribution | Worldwide - US Nationwide distribution including in the states of Alabama, Arizona, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, N |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.