FDA Device recall Z-2383-2021
CoolSculpting Elite System The CoolSculpting System SW release 2.0, SW release 3.0, SW release 3.0.1, SW release 3.0.2
- FDA Device
- Class II
- terminated
- Published 2021-09-08
On 2021-09-08 the FDA classified a Class II recall of CoolSculpting Elite System The CoolSculpting System SW release 2.0, SW release 3.0, SW release 3.0.1, SW release 3.0.2 by Zeltiq Aesthetics, citing 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)….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2383-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-07-05 |
| Published | 2021-09-08 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Zeltiq Aesthetics |
| Distribution | 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, PR, SC, TN, TX, UT, VA, VT, WA, WI, WV, WY |
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
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.
Identifiers
| code_info | Model Numbers: CoolSculpting Elite System: CS-S3-002-D-00 and CS-S3-002-D-00_R Surface 150 (S150) Applicator: CS-A3-15S…Model Numbers: CoolSculpting Elite System: CS-S3-002-D-00 and CS-S3-002-D-00_R Surface 150 (S150) Applicator: CS-A3-15S-00 UDI: CoolSculpting Elite System: 00816417021619 Surface 150 (S150) Applicator: 00816417021718 SW release 2.0, SW release 3.0, SW release 3.0.1, SW release 3.0.2 Serial Numbers: U.S.: D012020134001; D012020134009; D012020134014; D012020134015; D012020142001; D012020142002; D012020142003; D012020142004; D012020142005; D012020142006; D012020142007; D012020142012; D012020142013; D012020142014; D012020142015; D012020142016; D012020148001; D012020148002; D012020148003; D012020148004; D012020148005; D012020148006; D012020148007; D012020148010; D012020148011; D012020148012; D012020148013; D012020148014; D012020149001; D012020149003; D012020149004; D012020149006; D012020149007; D012020149008; D012020149010; D012020149011; D012020149012; D012020149013; D012020149014; D012020149015; D012020149016; D012020156002; D012020156004; D012020156005; D012020156006; D012020156 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2383-2021%22
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