# FDA recall Z-1889-2024

> **Channel Medsystems, Inc.** · Class II · device recall initiated 2024-05-03.

## 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 th

## 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).

## 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.

## Key facts

- **Recall number:** Z-1889-2024
- **Recalling firm:** Channel Medsystems, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-05-03
- **Report date:** 2024-05-29

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Berkeley, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1889-2024

## Citation

> AI Analytics. FDA recall Z-1889-2024. Retrieved 2026-07-09 from https://api.ai-analytics.org/recall/Z-1889-2024. Source: US FDA. Licensed CC0.

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