Reported Sep 8, 2021 · Terminated
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.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Zeltiq Aesthetics, Inc · 4410 Rosewood Dr · Pleasanton, CA · 94588-3050
Is this the product you have?
- CoolSculpting Elite System The CoolSculpting System SW release 2.0, SW release 3.0, SW release 3.0.1, SW release 3.0.2
- Lot codes and dates
867 of 867 products
Products covered by this recall # Barcodes Product as published 1 0081641702161900816417021718Model 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 2 D012020134009 3 D012020134014 4 D012020134015 5 D012020142001 6 D012020142002 7 D012020142003 8 D012020142004 9 D012020142005 10 D012020142006 11 D012020142007 12 D012020142012 13 D012020142013 14 D012020142014 15 D012020142015 16 D012020142016 17 D012020148001 18 D012020148002 19 D012020148003 20 D012020148004 - Amount recalled
- 911 systems (update 08/23/2021 = 1105 systems)
Where it was sold
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.
This product could cause temporary or reversible health problems — stop using it.
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