Channel Medsystems recalls Cerene Cryotherapy Device (FGS-7000) due to error code 003 not being listed in troubleshooting instructions. This may cause incorrect device operation during endometrial ablation procedures.
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).
Channel Medsystems recalls their Cerene Cryotherapy Device (FGS-7000) because error code 003 is missing from the troubleshooting instructions. This could lead to incorrect device operation during endometrial ablation procedures, which are used to reduce menstrual bleeding.
The device uses nitrous oxide to freeze the endometrium. Error code 003 is not listed in the troubleshooting instructions, which could lead to incorrect device operation during procedures. This might cause the procedure to be less effective or require additional steps.
Healthcare professionals who use the Cerene Cryotherapy Device for endometrial ablation procedures are affected. Those who have the FGS-7000 model with non-expired lots manufactured through February 2024 are most at risk.
The Cerene Cryotherapy Device (FGS-7000) with non-expired lots manufactured through February 2024. Check the model number on the device and the lot numbers listed in the recall notice.
Review the troubleshooting section for error code 003 to confirm if it's listed.
The device is safe to use if error code 003 is listed in the troubleshooting instructions. Otherwise, it may not operate correctly during procedures.
Check if your device has the FGS-7000 model with non-expired lots manufactured through February 2024. If so, review the troubleshooting instructions for error code 003.
The recall does not provide a specific fix. Users should check if error code 003 is listed in the troubleshooting instructions.
We’ve drafted a message you can send Cerene to request your refund or repair — edit it as you like.
Subject: Recall Z-1889-2024 — Cerene Cerene Hello, I own a Cerene that is covered by recall Z-1889-2024 from Cerene. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
