Zeltiq Aesthetics, Inc Recall 88397
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
Zeltiq Aesthetics, Inc Recall 88397 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2383-2021 |
| Event ID | 88397 |
| Event 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 |
| Product Type | Devices |
| 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. |
| Quantity | 911 systems (update 08/23/2021 = 1105 systems) |
| Recall 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 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. |
| Device Classification | 20210908 |
| Device 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; 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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; 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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; 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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; |
| Center Classification Date | 20210827 |
| Recall Initiation Date | 20210705 |
| Recalling Firm | Zeltiq Aesthetics, Inc |
| Initial Notification | Letter |
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