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.
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.
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.
The device's error messaging system may incorrectly report thermal events or fail to report them at all. This could cause users to re-treat the same area within 24 hours without realizing it, or continue treatments without knowing a thermal event happened, potentially leading to repeated treatments on the same area.
Users of the CoolSculpting Elite System with software versions 2.0 through 3.0.2 are affected. Those who have undergone treatment with this system and are still using the device are at risk of re-treating the same area without knowing it occurred.
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.
Verify your CoolSculpting Elite System software version by checking the device settings or documentation.
If you have an affected version, update to the latest software version to fix the error messaging issue.
Software versions 2.0, 3.0, 3.0.1, and 3.0.2 are affected.
Check your device's software version in the settings or documentation. Affected devices have model numbers CS-S3-002-D-00 or CS-S3-002-D-00_R Surface 150 (S150) Applicator: CS-A3-15S-00.
No, but you should update the software to the latest version to fix the error messaging issue.
We’ve drafted a message you can send Zeltiq Aesthetics to request your refund or repair — edit it as you like.
Subject: Recall Z-2383-2021 — Zeltiq Aesthetics Zeltiq Aesthetics Hello, I own a Zeltiq Aesthetics that is covered by recall Z-2383-2021 from Zeltiq Aesthetics. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
