FDAMay 3, 2024device

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 menstru...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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).

What to do

FDA enforcement status: Ongoing

Brands named

channel medsystemschannel

UPCs

008500085950352024101635693

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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