Use caution Medical device recall · FDA · Published July 5, 2021

Zeltiq CoolSculpting Elite System SW 2.0-3.0.2 Recall: Error Messaging Risk

Zeltiq Aesthetics recalls CoolSculpting Elite System software versions 2.0 through 3.0.2 due to potential error messaging that could cause users to re-treat areas within 24 hours or miss thermal events.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2383-2021Medical device Zeltiq Aesthetics ›

Use caution until it’s fixed

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.

Take action

Contact the company

Recalling firmZeltiq Aesthetics, Inc4410 Rosewood Dr · Pleasanton, CA 94588-3050

✎ GovInfoNow plain-language explainer

Zeltiq Aesthetics is recalling CoolSculpting Elite System software versions 2.0 through 3.0.2 because of an error messaging system that might cause users to re-treat the same area within 24 hours or not notice thermal events. This could lead to repeated treatments without awareness of potential risks. Read more at govinfonow.com/recall/62242-zeltiq-coolsculpting-elite-system-sw-2-0-3-0-2.

Source Summary by GovInfoNow · govinfonow.com/recall/62242-zeltiq-coolsculpting-elite-system-sw-2-0-3-0-2 · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2383-2021

Cite this page

“Zeltiq CoolSculpting Elite System SW 2.0-3.0.2 Recall: Error Messaging Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62242-zeltiq-coolsculpting-elite-system-sw-2-0-3-0-2. Based on FDA recall #Z-2383-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2383-2021%22&limit=1).

The Food and Drug Administration announced on July 5, 2021, that Zeltiq Aesthetics, Inc. is recalling the CoolSculpting Elite System due to an incorrect error messaging system. The agency said the defect could lead users to re-treat an area within 24 hours or continue treating without knowing a thermal event occurred.

How to tell if you have it

Brand: Zeltiq Aesthetics
Product: CoolSculpting Elite System
Software releases: SW release 2.0, SW release 3.0, SW release 3.0.1, SW release 3.0.2
Model Numbers: CS-S3-002-D-00 and CS-S3-002-D-00_R (System); CS-A3-15S-00 (Surface 150 Applicator)
UDI: 00816417021619 (System); 00816417021718 (Applicator)
Units affected: 911 systems (updated to 1105 on Aug. 23, 2021)

The hazard

According to the FDA, an incorrect error messaging system could potentially lead to reporting a thermal event error causing a user to re-treat the affected anatomic area within 24 hours. It could also cause a user not to report a thermal event or any other error codes, leading them to continue treating without being aware that a thermal event has occurred.

Context

GovInfoNow's records show Zeltiq Aesthetics, Inc. has 1 other recall on record since 2022-06-09. On 2022-06-09, the company recalled CoolMax ZELTIQ Vacuum Applicators due to a risk of Paradoxical Hyperplasia. Other recent recalls of similar products include Elekta MOSAIQ Oncology System Recall (2025-12-10), Elekta MOSAIQ Oncology System Software Recall (2026-05-21), and GE Medical Systems Portrait Compute V1.2 Software Recall (2026-07-20).

How to tell if you have this one

Check for CoolSculpting Elite System with software versions 2.0, 3.0, 3.0.1, or 3.0.2. The model numbers are CS-S3-002-D-00 and CS-S3-002-D-00_R Surface 150 (S150) Applicator: CS-A3-15S-00. Serial numbers are listed in the recall notice.

Brand
Zeltiq Aesthetics
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Software Version
Verify your CoolSculpting Elite System software version by checking the device settings or documentation.
Update Software
If you have an affected version, update to the latest software version to fix the error messaging issue.

Where it went and when

Where it was distributed

Distributed in 43 states and Puerto Rico, and outside the U.S.

FDA 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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alabama, Arizona, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming.

Recall timeline

FDA terminated this recall 2.3 years after the firm started it.

Jul 5, 2021Firm started the recall
Aug 27, 2021FDA classified it Class II
Sep 8, 2021Published in FDA’s Enforcement Report
Nov 9, 2023FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

Similar recalls

Latest medical device recalls

Keep exploring

More Zeltiq Aesthetics recalls

Link to this recall

<a href="https://govinfonow.com/recall/62242-zeltiq-coolsculpting-elite-system-sw-2-0-3-0-2">Zeltiq CoolSculpting Elite System SW 2.0-3.0.2 Recall: Error Messaging Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-2383-2021 (July 5, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2383-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.