Class II Recall

CoolSculpting Elite System The CoolSculpting System SW release 2.0, SW release 3.0, SW release 3.0.1, SW release 3.0.2

Summary

The FDA issued a Class II for CoolSculpting Elite System The CoolSculpting System SW release 2.0, SW release 3 by Zeltiq Aesthetics, Inc. 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 anat.

Details

Source

Device Recall

External ID

Z-2383-2021

Action Date

2021-09-08

Status

Terminated

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

Lot/Code Info: 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; D012020156009; D012020156011; D012020156012; D012020156013; D012020156015; D012020156016; D012020160003; D012020160004; D012020160006; D012020160008; D012020160009; D012020160010; D012020160013; D012020160014; D012020160015; D012020160016; D012020162001; D012020162002; D012020162003; D012020162004; D012020162005; D012020162006; D012020162007; D012020162008; D012020162009; D012020162011; D012020162012; D012020162013; D012020162015; D012020168002; D012020168003; D012020168004; D012020168005; D012020168006; D012020168007; D012020168008; D012020168010; D012020168011; D012020168012; D012020168014; D012020168016; D012020170001; D012020170003; D012020170004; D012020170005; D012020170006; D012020170007; D012020170008; D012020170009; D012020170010; D012020170012; D012020170016; D012020175003; D012020175006; D012020175007; D012020175010; D012020175011; D012020175015; D012020181002; D012020181003; D012020181005; D012020181006; D012020181007; D012020181009; D012020181011; D012020181015; D012020181016; D012020188001; D012020188002; D012020188003; D012020188004; D012020188005; D012020188006; D012020188007; D012020188008; D012020188009; D012020188011; D012020188013; D012020188014; D012020190003; D012020190004; D012020190005; D012020190006; D012020190008; D012020190009; D012020190010; D012020190012; D012020190014; D012020191001; D012020191002; D012020191003; D012020191004; D012020191008; D012020191009; D012020191010; D012020191013; D012020191014; D012020191015; D012020191016; D012020195001; D012020195002; D012020195005; D012020195006; D012020195007; D012020195009; D012020195011; D012020195016; D012020198001; D012020198004; D012020198008; D012020198009; D012020198010; D012020198011; D012020198012; D012020198013; D012020198014; D012020198015; D012020203001; D012020203003; D012020203005; D012020203006; D012020203007; D012020203011; D012020203015; D012020203016; D012020203017; D012020219002; D012020219003; D012020219011; D012020219013; D012020219014; D012020224001; D012020224003; D012020224004; D012020224005; D012020224008; D012020224009; D012020224012; D012020224013; D012020226001; D012020226002; D012020226004; D012020226006; D012020226007; D012020226008; D012020226009; D012020226010; D012020226012; D012020226014; D012020240001; D012020240002; D012020240003; D012020240008; D012020240012; D012020240013; D012020246001; D012020246004; D012020246005; D012020246011; D012020246016; D012020253003; D012020253005; D012020253006; D012020253007; D012020253008; D012020253011; D012020253012; D012020253013; D012020253016; D012020256001; D012020256002; D012020256009; D012020256010; D012020256011; D012020256012; D012020256013; D012020260002; D012020260003; D012020260004; D012020260005; D012020260009; D012020260015; D012020273003; D012020273004; D012020273008; D012020273011; D012020273012; D012020273015; D012020273016; D012020275001; D012020275003; D012020275004; D012020275005; D012020275006; D012020275007; D012020275014; D012020275015; D012020280001; D012020280006; D012020280014; D012020283004; D012020283005; D012020283007; D012020283008; D012020283010; D012020283011; D012020283012; D012020283013; D012020283015; D012020296001; D012020296002; D012020296003; D012020296004; D012020296005; D012020296007; D012020296008; D012020296009; D012020296015; D012020301001; D012020301002; D012020301003; D012020301004; D012020301005; D012020301009; D012020301010; D012020301012; D012020301013; D012020302001; D012020302003; D012020302005; D012020302007; D012020302008; D012020302009; D012020302010; D012020302011; D012020302013; D012020302014; D012020302016; D012020307002; D012020307004; D012020307005; D012020307007; D012020307009; D012020307012; D012020307013; D012020307016; D012020309001; D012020309005; D012020309006; D012020309010; D012020309012; D012020309013; D012020309015; D012021029001; D012021029007; D012021029009; D012021029012; D012021029013; D012021029014; D012021029016; D012021032002; D012021032009; D012021032012; D012021032015; D012021074002; D012021074003; D012021074005; D012021074006; D012021074007; D012021074008; D012021074009; D012021074010; D012021074012; D012021074013; D012021074015; D012021074016; D012021075002; D012021075005; D012021075006; D012021075007; D012021075008; D012021075009; D012021075010; D012021075011; D012021075012; D012021075013; D012021075015; D012021077002; D012021077003; D012021077004; D012021077006; D012021077007; D012021077008; D012021077009; D012021077010; D012021077014; D012021077015; D012021077016; D012021081001; D012021081002; D012021081003; D012021081004; D012021081007; D012021081009; D012021081010; D012021081011; D012021081012; D012021081013; D012021081015; D012021081016; D012021082001; D012021082002; D012021082004; D012021082005; D012021082006; D012021082007; D012021082009; D012021082010; D012021082011; D012021082012; D012021082013; D012021082014; D012021082016; D012021085001; D012021085003; D012021085005; D012021085007; D012021085008; D012021085009; D012021085010; D012021085015; D012021089001; D012021089002; D012021089003; D012021089005; D012021089007; D012021089009; D012021089010; D012021089012; D012021089013; D012021089015; D012021093001; D012021093002; D012021093005; D012021093006; D012021093009; D012021093010; D012021093011; D012021093014; D012021093016; D012021096001; D012021096003; D012021096004; D012021096005; D012021096006; D012021096007; D012021096010; D012021096012; D012021096013; D012021096015; D012021097001; D012021097004; D012021097006; D012021097007; D012021097008; D012021097009; D012021097010; D012021097011; D012021097012; D012021105002; D012021105003; D012021105004; D012021105006; D012021105010; D012021105012; D012021105014; D012021105015; D012021110001; D012021110003; D012021110004; D012021110005; D012021110007; D012021110008; D012021110009; D012021110012; D012021110013; D012021110014; D012021110015; D012021110016; D012021111001; D012021111002; D012021111003; D012021111007; D012021111008; D012021111009; D012021111010; D012021111012; D012021111014; D012021111015; D012021111016; D012021113001; D012021113002; D012021113004; D012021113006; D012021113007; D012021113009; D012021113013; D012021113014; D012021113015; D012021113016; D012021116003; D012021116007; D012021116008; D012021116009; D012021116011; D012021116012; D012021116013; D012021116014; D012021118001; D012021118002; D012021118003; D012021118004; D012021118005; D012021118006; D012021118007; D012021118008; D012021118009; D012021118010; D012021118011; D012021118012; D012021118013; D012021118014; D012021118015; D012021118016; D012021123001; D012021123003; D012021123007; D012021123008; D012021123009; D012021123011; D012021123012; D012021123014; D012021124001; D012021124002; D012021124003; D012021124005; D012021124007; D012021124009; D012021124010; D012021124011; D012021124012; D012021124013; D012021125001; D012021138002; D012021138003; D012021138006; D012021138007; D012021138008; D012021138009; D012021138011; D012021138013; D012021138014; D012021138015; D012021138016; D012021141001; D012021141002; D012021141003; D012021141004; D012021141005; D012021141006; D012021141009; D012021141010; D012021141011; D012021141012; D012021141013; D012021141015; D012021141016; D012021144001; D012021144003; D012021144004; D012021144005; D012021144007; D012021144009; D012021144011; D012021144012; D012021144013; D012021144014; D012021146002; D012021146005; D012021146006; D012021146008; D012021146010; D012021146011; D012021146013; D012021146015; D012021146016; D012021148002; D012021148003; D012021148004; D012021148006; D012021148007; D012021148008; D012021148010; D012021148014; D012021148015; D012021148016; D012021160001; D012021160006; D012021160007; D012021160008; D012021160009; D012021160010; D012021160011; D012021160013; D012021160016; D012021162002; D012021162007; D012021162009; D012021162010; D012021162011; D012021162012; D012021162013; D012021162014; D012021162015; D012021162016; D012021166001; D012021166002; D012021166003; D012021166004; D012021166005; D012021166007; D012021166008; D012021166009; D012021166011; D012021166012; D012021166013; D012021166015; D012021166016; D012021168001; D012021168003; D012021168006; D012021168007; D012021168008; D012021168009; D012021168012; D012021168014; D012021168015; D012021168016; D012021172001; D012021172003; D012021172005; D012021172006; D012021172008; D012021172009; D012021172012; D012021172013; D012021173001; D012021173002; D012021173003; D012021173004; D012021173005; D012021173006; D012021173007; D012021173008; D012021173010; D012021173015; D012021173016; D012021175001; D012021175002; D012021175004; D012021175005; D012021175007; D012021175008; D012021175010; D012021175011; D012021175012; D012021175014; D012021175016; D012021179002; D012021179004; D012021179005; D012021179007; D012021179009; D012021179010; D012021179013; D012021179014; D012021179015; D012021179016; D012021180002; D012021180003; D012021180004; D012021180005; D012021180007; D012021180008; D012021180009; D012021180010; D012021180012; D012021180013; D012021181002; D012021181006; D012021181007; D012021181011; D012021181014; D012021181015; D012021181016; D012021187002; D012021187003; D012021187004; D012021187007; D012021187009; D012021187010; D012021187011; D012021187012; D012021187013; D012021187014; D012021187015; D012021187016; D012021188001; D012021188002; D012021188003; D012021188006; D012021188008; D012021188009; D012021188010; D012021188011; D012021188012; D012021188013; D012021188015; D012021188016; D012021189002; D012021189004; D012021189005; D012021189006; D012021189008; D012021189009; D012021189013; D012021193003; D012021193006; D012021193008; D012021193010; D012021193012; D012021193013; D012021193015; D012021193016; D012021195001; D012021195002; D012021195003; D012021195004; D012021195005; D012021195007; D012021195008; D012021195009; D012021195014; D012021195016; D012021197001; D012021197002; D012021197004; D012021197005; D012021197006; D012021197007; D012021197009; D012021197011; D012021197015; D012021201002; D012021201003; D012021201004; D012021201005; D012021201006; D012021201007; D012021201008; D012021201010; D012021201011; D012021201014; D012021202001; D012021202004; D012021202006; D012021202007; D012021202009; D012021202010; D012021202011; D012021202012; D012021202013; D012021202016; D012021204002; D012021204003; D012021204006; D012021204010; D012021204013; D012021204014; D012021204016; D012021208001; D012021208002; D012021208003; D012021208005; D012021208006; D012021208007; D012021208012; D012021208016; D012021210002; D012021210004; D012021210005; D012021210007; D012021214003; D012021214009; D012021215007; D012021215013; D012021216013; D012021216015; D012021217011; D012021224002; D012021224009; D012021224010; D012021216005; D012021210012; D012021224016; D012021224008; O.U.S.: D212020314015; D212021020012; D212020316006; D212020287004; D212020293013; D212020245005; D212020314002; D212020245016; D212020295008; D212020314014; D212020316010; D212020293007; I212021125006; D212020287006; D212020295015; D212021025005; D212020316003; D212020316007; D212021004013; D212020293010; D212020287003; D212020245007; D212020295013; D212020318011; D212020314005; D212020293003; D212021028003; D212020295012; D212020318015; D212020295016; D212020293002; D212020314009; D212020295009; D212020316011; D212020293016; D212020318005; D212021020005; D212020318003; D212020318008; D212020287002; D212020323015; D212020318014; D212020293011; D212020325003; D212020314007; D212020318001; D212020318013; D212020287010; D212020316014; D212020316015; D212020314010; D212020325015; D212020245013; D212021023001; D212020323007; D212020287008; D212020325007; D212020323009; D212020314006; D212020314016; D212020323003; D212021004011; D212021004012; D212020325002; D212021004006; D212020295002; D212020314013; D212020245002; D212020287014; D212020318002; D212020316008; D212020318007; D212020325010; D212020293015; D212020314008; D212020325016; D212020323016; D212020314011; D212021023003; D212020287009; D212021020014; D212020323005; D212021020013; D212020325008; D212020314001; D212020245010; D212021004008; D212020316012; D212020245004; D212020314012; D212020325014; D212021023010; D212020325004; D212021025015; D212020318016; I212021005005; D212020287011; D212020245006; D212020295005; D212020316016; D212021004007; D212020316004; D212020245015; D212020293012;

Quantity Affected: 911 systems (update 08/23/2021 = 1105 systems)

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.

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.

Type: Voluntary: Firm initiated

Recall Initiated: 2021-07-05

Company

Zeltiq Aesthetics, Inc

Pleasanton, CA

Context & Analysis

This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.

This was one of 126 device recalls issued in the same week, part of 403 device-related FDA actions this month.

Zeltiq Aesthetics, Inc has 9 FDA actions in our database, including 6 recalls and 3 clearances.

Frequently Asked Questions

What is a Class II recall?

A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.

What should I do if I have this product?

Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Zeltiq Aesthetics, Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.

How often does Zeltiq Aesthetics, Inc have FDA actions?

Zeltiq Aesthetics, Inc has 9 FDA actions in our database, including 6 recalls and 3 device clearances.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "Z-2383-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

Want to know the moment something like this happens?

Get alerts for device

Related Actions

MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, IC Tray REF: 888810200

Covidien LP · 2023-08-23

Sterile Procedural Trays, labeled as the following: a. BREAST AUGMENTATION b. BREAST REDUCTION CDS c. CUH ABDOMINO

MEDLINE INDUSTRIES, LP - Northfield · 2023-02-15

VTC Regular Kit Nephrostomy Catheter System Kit, Material Number REF M001245300; to provide external drainage of the uri

Boston Scientific Corporation · 2024-09-25

EnChroma Safety Glasses with Rx Indoor Universal Lenses: Martinez Cx1 Indoor Rx, SKU: Cx.PC.IN.MTZ.BK.Rx; Summit Indoo

Enchroma Inc · 2024-11-27

Otological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309;

Adept Medical Ltd · 2025-01-29