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

FDA device recall Z-1889-2024 · posted 2024-05-23 · Open, Classified

Recall details

Recalling firm

Channel Medsystems, Inc.

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).

Action taken

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.

Root cause

Device Design

Status

Open, Classified

Product code

MNB

Quantity affected

1772

Distribution

Worldwide - US Nationwide distribution including in the states of Alabama, Arizona, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Kentucky, Louisian

Date initiated

2024-05-03

Date posted

2024-05-23

Location

Berkeley, CA