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U.S. Department of Health and Human Services

Class 2 Device Recall CoolSculpting Elite System

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  Class 2 Device Recall CoolSculpting Elite System see related information
Date Initiated by Firm July 05, 2021
Date Posted August 27, 2021
Recall Status1 Open3, Classified
Recall Number Z-2383-2021
Recall Event ID 88397
510(K)Number K193566  
Product Classification Dermal cooling pack/vacuum/massager - Product Code OOK
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
Code Information Model 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; D012020134009; D012020134014; D012020134015; D012020142001; D012020142002; D012020142003; D012020142004; D012020142005; D012020142006; D012020142007; D012020142012; D012020142013; D012020142014; D012020142015; D012020142016; D012020148001; D012020148002; D012020148003; D012020148004; D012020148005; D012020148006; D012020148007; D012020148010; D012020148011; D012020148012; D012020148013; D012020148014; D012020149001; D012020149003; D012020149004; D012020149006; D012020149007; D012020149008; D012020149010; D012020149011; D012020149012; D012020149013; D012020149014; D012020149015; D012020149016; D012020156002; D012020156004; D012020156005; D012020156006; D012020156007; 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Recalling Firm/
Manufacturer		 Zeltiq Aesthetics, Inc
4410 Rosewood Dr
Pleasanton CA 94588-3050
For Additional Information Contact Nicole Katz
862-261-7084
Manufacturer 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.
FDA Determined
Cause 2		 Software design
Action 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.
Quantity in Commerce 911 systems (update 08/23/2021 = 1105 systems)
Distribution U.S.: AL, AR, AZ, CA, CO, CT, FL, GA,HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, SC, TN, TX, UT, VA, VT, WA, WI, WV, and WY. O.U.S.: Italy, Norway, Sweden, France, Netherlands, Germany, Spain, United Kingdom, Portugal, South Korea, Singapore, and Hong Kong.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = OOK and Original Applicant = ZELTIQ Aesthetics, Inc.
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