FDAJuly 5, 2021device
CoolSculpting Elite System The CoolSculpting System SW release 2.0, SW release 3.0, SW release 3.0.1, SW release 3.0.2
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
An incorrect error messaging system that could potentially lead to: 1) Reporting a thermal event error causing a user to re-treating the affected anatomic area within 24 hours, 2) Not reporting a thermal event or any other error codes causing a user to continue treating without being aware that a thermal event has occurred.
What to do
FDA enforcement status: Terminated
Brands named
zeltiq aestheticszeltiq
UPCs
0081641702161900816417021718
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDACoolCurve ZELTIQ Vaccum Applicator REF BRZ-AP1-062-0002022-06-09
- FDACoolMax ZELTIQ Vacuum Applicator REF BRZ-AP1-080-0002022-06-09
- FDACoolCore ZELTIQ Vacuum Applicator REF BRZ-AP1-063-0002022-06-09
- FDACoolCurve+ ZELTIQ Vacuum Applicator REF BRZ-AP1-064-0002022-06-09
- FDACoolFit ZELTIQ Vacuum Applicator REF BRZ-AP1-066-0002022-06-09
- FDAAction De Gala, FuSion Conductive Gel - Product Usage: Intended for use in acoustic coupling of ultrasound transducer to tissue.2021-08-23
- FDASUNG HWAN E&B VIVACE Shenb Innovation of Beauty Technologyt - Product Usage: intended for use in the dermatologic and surgical procedures for electrocoagulation and hemostasis, and the percutaneous treatment of facial wrinkles.2020-03-13
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