Zeltiq Aesthetics, Inc CoolSculpting Elite System The CoolSculpting System SW release 2.0, SW release 3.0, SW release 3.0.1, SW release 3.0.2 Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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.

Recommended Action

Per FDA guidance

On 07/13/2021 and 7/23/2021, the firm sent "URGENT" product correction notifications to customers informing that software updates were needed to correct error messaging bugs. As a result of the bugs thermal events 1) may not lead to "thermal event" error message alert and treatment would not be stopped; or 2) the error text displayed may be unrelated and the provider would not know to avoid retreatment within 24 hours. These could result in cold-induced injury and 2nd or 3rd degree freeze burns. No injuries have been reported. The firm also informed customers that a corrective software update was deployed remotely to all units and 1) to initiate the update by performing a soft power cycle from the touchscreen; 2) to be aware that the 5 minute process could not be delayed or deferred; 3) not to power off the device during update; 4) to restart the device after update; 5) to verify the successful installation by pressing TOOLS ABOUT, scroll to column Software Release, which should show 3.1.0; and 6) that the software update must be completed before continuing to use the system. If customers have not received the notification of the update on the System or the update did not complete, they should contact product support at 1-888-935-8471 or email at CoolSculpting.support@allergan.com.*** ***Updated/Revised: On 08/26/2021, the firm sent an update/revised "URGENT MEDICAL DEVICE CORRECTION" Notification Letter via email informing its customers to cease use of the CoolSculpting Elite Devices until further notice. The updated communication instructed customers to refrain from using affected devices until the Recalling Firm notifies them because the software change needs to be submitted to FDA for review. For further assistance contact Product Support at 1-888-935-8471 (6am to 5pm PST) or CoolSculpting.support@allergan.com.

Distribution

As reported by FDA

AL, AZ, AR, CA, CO, CT, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MO, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, TN, TX, UT, VT, VA, WA, WV, WI, WY, PR