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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 88397

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
July 05, 2021
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Zeltiq Aesthetics, Inc

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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

Z-2383-2021
Recall number
Z-2383-2021
Initiated
July 05, 2021
Classification
Class II
Status
Terminated
Recalling firm
Zeltiq Aesthetics, Inc
Quantity
911 systems (update 08/23/2021 = 1105 systems)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

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.

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; 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;

Distribution pattern

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.

Field note

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