Z-1889-2024Class II

Brand Name: Cerene Cryotherapy Device Product Name: DEVICE, THERMAL ABLATION, ENDOMETRIAL Model/Catalog...

Name: Z-1889-2024 Brand Name: Cerene Cryotherapy Device Product Name: DEVICE, THERMAL ABLATION, ENDOMETRIAL Model/Catalog...
Creator: Channel Medsystems, Inc.
Published: 2024-05-03
License: https://open.fda.gov/license/

Channel Medsystems / initiated 2024-05-03 / Open, Classified / root cause: design

FDA source

Channel Medsystems, Inc. began a recall of Brand Name: Cerene Cryotherapy Device Product Name: DEVICE, THERMAL ABLATION, ENDOMETRIAL Model/Catalog Number: FGS-7000 Product Description: The Cerene... on 2024-05-03. FDA classified it as Class II and gives the reason as "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)". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1889-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-05-03
Posted: 2024-05-23
Recalling firm: Channel Medsystems
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 bleeding. The device is intended for use by healthcare professionals who have received appropriate training and are familiar with the principles, clinical applications, complications, side effects, and hazards commonly associated with endometrial ablation. The Cerene Device is single use, disposable, and provided sterile. The average procedure time is 7 minutes, with 2.5 minutes of active cryoablation. Ablation is achieved throughout the uterine cavity through the use of cryothermic energy. The cryothermic energy is provided by a liquid-to-gas phase change of N2O. During the 2.5-minute treatment cycle, liquid N2O (originating from a small Cylinder located in the device handle) flows through a delivery line and into an inflow line with multiple jets. This liquid N2O is infused into an ultra-thin polyurethane Liner, where it converts into gas. The gaseous N2O is exhausted through the Exhaust Hose exiting the bottom of the handle. Component: N/A
Product code: MNB Device, Thermal Ablation, Endometrial
Reason for recall: 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 tag: design
FDA 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 Treated, End procedure, Do NOT re-treat or Uterus Treated End procedure Do NOT re-treat as the Treatment Status & Next Steps matching the corresponding displayed Cerene Device LCD screen message/error code 003. Customer are instructed to: 1. Follow your facility s established procedures for handling updated labeling/documents, such as immediately providing a copy of this notice to relevant healthcare professionals and notifying them of the updated IFU (Troubleshooting) and its online availability. 2. No product is being recalled and you are not required to return devices or IFUs to Channel Medsystems. 3. Complete and return the acknowledgment form at the end of this urgent field safety notice within one month of receipt. Questions or assistance - contact the firm at 510-338-9301 or email [email protected] during Office Hours: Monday through Friday. 8:00 AM to 5:00 PM, Pacific Time.
Quantity in commerce: 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, New Hampshire, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Wisconsin and the country of Netherlands.
Product codes and lots: Lot Code: Model No: FGS-7000 UDI-DI: 00850008595035 Lot Numbers: All non-expired lots manufactured through February 2024 101635693, 101635694, 101635695, 101635696, 102211255, 102211256, 102211257, 102211258, 102887363, 102887364, 103151029, 103151030, 103151031, 103151032, 103489753, 103489754, 103489755, 103489756, 103489757, 103925402, 104008714, 104008715, 104521903, 104521904, 104521905, 104521906, 104521907, 104808352, 104808353, 105418198, 105733204, 105733205

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1889-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1889-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-29	2024-05-23

Product code MNB

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)