Brand Name: Cerene Cryotherapy Device Product Name: DEVICE, THERMAL ABLATION, ENDOMETRIAL Model/Catalog Number: FGS-7000

FDA device recall Z-1584-2025 · posted 2025-04-16 · Open, Classified

Recall details

Recalling firm

Channel Medsystems, Inc.

Reason for recall

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

Action taken

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 facility s procedures. 4. Complete and return the customer acknowledgement form. It may be that you no longer have any physical inventory on site. Completing this form will allow us to update our records and will also negate the need for us to send any further unnecessary communications on this matter. Therefore, please complete the form even if you no longer have any of the affected devices in your physical inventory. 5. Circulate this letter to all other relevant parties, as needed. For questions, contact Channel Medsystems at safetynotice@cerene.com or at (510)338-9301 Monday thru Friday 8:00 AM to 5:00 PM Pacific Time

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

MNB

Quantity affected

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.

Date initiated

2025-03-20

Date posted

2025-04-16

Location

Berkeley, CA