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CoolSculpting Elite System recallZ-2383-2021 · Zeltiq Aesthetics, Inc · initiated Jul 5, 2021

Terminated

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Zeltiq Aesthetics, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: Software design

What the company is doing

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 [email protected].*** ***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 [email protected].

Recall details

Recall number
Z-2383-2021
Status
Terminated
Initiated by the company
Jul 5, 2021
Posted by the FDA
Aug 27, 2021
Recalling firm
Zeltiq Aesthetics, Inc
Quantity
911 systems (update 08/23/2021 = 1105 systems)
Product code
OOK
FDA submissions
K193566
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.

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

Code information (models, lots, serial numbers)

Show the full code information (13k characters)

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; D012020156008; 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Devices named in this recall

2 devices in the FDA device registry whose identifier appears in the recall's code information.

Sources and updates

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