FDA-Device2021-09-08Class II
CoolSculpting Elite System The CoolSculpting System SW release 2.0, SW release 3.0, SW release 3.0.1, SW release 3.0.2
Zeltiq Aesthetics, Inc
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.
Sold states
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.
Affected count
911 systems (update 08/23/2021 = 1105 systems)
Manufactured in
4410 Rosewood Dr, N/A, Pleasanton, CA, United States
Products
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 notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2383-2021Don't want to check this manually?
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