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Zeltiq Aesthetics, Inc recalls CoolSculpting Elite System The CoolSculpting System SW release 2.0, SW release 3.0, SW release 3.0.1, SW release 3.0.2
Recalled September 8, 2021 · FDA recall Z-2383-2021 · Zeltiq Aesthetics
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. · FDA Class II
Units
911 systems (update 08/23/2021 = 1105 systems)
Sold at
U.S.: AL, AR, AZ, CA, CO, CT, FL, GA,HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, SC, TN, TX, UT, VA, VT, WA, WI, WV, and WY. O.U.S.: Italy, Norway, Sweden, France, Netherlands, Germany, Spain, United Kingdom, Portugal, South Korea, Singapore, and Hong Kong.
Description
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.
Product
CoolSculpting Elite System The CoolSculpting System SW release 2.0, SW release 3.0, SW release 3.0.1, SW release 3.0.2
Manufacturer(s)
Zeltiq Aesthetics, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →