Cerene Cryotherapy Device recall: missing error code in troubleshooting table
Channel Medsystems is recalling the Cerene Cryotherapy Device because error code 003 is missing from the device's troubleshooting documentation, which could prevent clinicians from properly diagnosing errors during use.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This FDA Class II recall involves a documentation completeness issue—a missing error code entry in the troubleshooting table. No injuries or illnesses have been reported, and the hazard is informational rather than a functional device defect. This fits the rubric criterion for minor labeling errors and documentation issues.
Plain-English summary
Channel Medsystems' Cerene Cryotherapy Device (Model FGS-7000) is being recalled because the Device Instructions for Use troubleshooting section is incomplete. Specifically, error code 003 does not appear in Table 22 (Summary of LCD Messages and Error Codes), even though the device may generate this error during clinical use.
The Cerene Device is an endometrial ablation system that uses cryothermic energy to reduce menstrual bleeding. It is designed for use by trained healthcare professionals in clinical settings. The missing error code from the troubleshooting table could prevent clinicians from properly diagnosing and responding to error code 003 if it occurs during a procedure.
This recall affects approximately 1,772 units distributed worldwide, including across the United States and the Netherlands. All non-expired lots manufactured through February 2024 are included in this recall.
Clinicians using the Cerene Device should verify that their copy of the Device Instructions for Use includes error code 003 in Table 22. Those with affected devices should contact Channel Medsystems for updated documentation or further instructions.
The recalled product
- Product
- 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 r
- Manufacturer
- Channel Medsystems, Inc.
- Hazard
- incomplete-documentation
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 101635694
- 101635695
- 101635696
- 102211255
- 102211256
- 102211257
- 102211258
- 102887363
- 102887364
- 103151029
- 103151030
- 103151031
- 103151032
- 103489753
- 103489754
- 103489755
- 103489756
- 103489757
- 103925402
- 104008714
Distribution
Distributed nationwide across the United States.
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