Zeltiq Aesthetics, Inc Recalls
Showing 1-2 of 2 recalls
CoolSculpting Elite System The CoolSculpting System SW release 2.0, SW release 3.0, SW release 3.0.1, SW release 3.0.2
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.
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.
CoolMax ZELTIQ Vacuum Applicator REF BRZ-AP1-080-000
Executing a voluntary discontinuation and removal of parallel plate applicators due to an increase complaint rate for adverse event Paradoxical Hyperplasia (HP) during the 2019 to 2021 timeframe.
On 06/09/2022, the Recalling firm started sending an "URGENT: MEDICAL DEVICE RECALL" Letter via FedEx Overnight service to customers informing them discontinue and return all CoolSculpting Parallel Plate Applicators (CoolCore, CoolCurve, CoolCurve+, CoolMax, and CoolFit) due to an increase in the rate of complaints for Paradoxical hyperplasia (PH) (also referred to as Paradoxical Adipose Hyperplasia-PAH) during 2019 to 2021 timeframe. Customers are instructed to: 1. If you have the affected applicators, discontinue further use and quarantine products prior to return. 2. Monitor patients that have undergone a procedure per your normal clinical practice. . 3. Conduct a physical count of the affected applicators in your possession and record the count on the enclosed Business Response Form. 4. Send the Business Response Form to Qualanex, LLC. via fax or email within five business days of receipt. To ensure we are able to account for all recalled product, it is imperative that you return the form. Please return the Business Response Form even if no recalled product is present. 5. When returning the recalled products, attach the prepaid FedEx Authorized Return shipping label to the outside of the return carton and return the recalled product to: Qualanex, LLC. 1410 Harris Road Libertyville, IL 60048 5. Please do not return any products that are not the subject of this recall to this address. For questions or assistance, contact: Product Returns Contact Qualanex, LLC 1-800-505-9291, 7:00am - 4:00pm CST or recall@qualanex.com Adverse Events/Product Complaints Contact ZELTIQ at: 1-800-624-4261, 8am 5pm CST Medical Information Contact ZELTIQ at: 1-800-678-1605 option #2, 8:30 am 5:00 pm EST or IR-Medcom@allergan.com For after hours assistance, please leave a voicemail or email. A response will be provided within 48 hours.