Recall Z-2383-2021— Zeltiq Aesthetics, Inc
Class II · Terminated
Class II FDA medical device recall by Zeltiq Aesthetics, Inc, initiated 2021-07-05, terminated 2023-11-09. It names one FDA 510(k) clearance: K193566. 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..
- Recalling firm
- Zeltiq Aesthetics, Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-07-05
- Terminated
- 2023-11-09
- Firm location
- Pleasanton, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.