CoolSculpting Elite System The CoolSculpting System SW release 2 recalled over fire hazard

Recall date

July 5, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

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

Recall number

Z-2383-2021

FDA classification

Class II

Brand / firm

Zeltiq Aesthetics, Inc

Sold / distributed

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…

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

CoolSculpting Elite System The CoolSculpting System SW release 2.0, SW release 3.0, SW release 3.0.1, SW release 3.0.2