# FDA recall Z-2383-2021

> **Zeltiq Aesthetics, Inc** · Class II · device recall initiated 2021-07-05.

## 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

## Reason for recall

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.

## Distribution

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.

## Key facts

- **Recall number:** Z-2383-2021
- **Recalling firm:** Zeltiq Aesthetics, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-07-05
- **Report date:** 2021-09-08
- **Termination date:** 2023-11-09

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Pleasanton, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2383-2021

## Citation

> AI Analytics. FDA recall Z-2383-2021. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-2383-2021. Source: US FDA. Licensed CC0.

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