Approximately 1,772 Cerene Cryotherapy Devices are being recalled because the Instructions for Use (IFU) manual is missing information for Error Code 003 in the troubleshooting section. These devices are used by healthcare professionals for endometrial ablation to reduce menstrual bleeding. The missing information could prevent users from correctly identifying and resolving system errors during the procedure. This recall affects all non-expired lots manufactured through February 2024, specifically Model FGS-7000.
If Error Code 003 occurs during a procedure and is not listed in the troubleshooting guide, it could lead to confusion or delays in treatment. This lack of instruction may result in the healthcare provider being unable to properly address a device malfunction, potentially impacting the safety or effectiveness of the clinical procedure.
Labeling update and technical guidance
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.