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U.S. Department of Health and Human Services

Class 2 Device Recall Cerene Cryotherapy Device

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  Class 2 Device Recall Cerene Cryotherapy Device see related information
Date Initiated by Firm May 03, 2024
Date Posted May 23, 2024
Recall Status1 Open3, Classified
Recall Number Z-1889-2024
Recall Event ID 94506
Product Classification Device, thermal ablation, endometrial - Product Code MNB
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
Code Information 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
Recalling Firm/
Manufacturer		 Channel Medsystems, Inc.
2919 7th St
Berkeley CA 94710-2704
For Additional Information Contact
510-338-9301
Manufacturer 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).
FDA Determined
Cause 2		 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 safetynotice@cerene.com 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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