CoolSculpting Elite System The CoolSculpting System SW release 2.0, SW release 3.0, SW release 3.0.1, SW release 3.0.2
Check against the official notice below — it lists the full affected range.
Zeltiq Aesthetics is recalling the CoolSculpting Elite System with software releases 2.0, 3.0, 3.0.1, and 3.0.2 due to an error in the system's error messaging. The faulty error messaging can either incorrectly report a thermal event error, potentially causing users to retreat the same area within 24 hours, or fail to report a thermal event entirely, allowing treatment to continue without alerting the user that a thermal event has occurred. Approximately 911 systems were initially affected, with the number increasing to 1,105 as of August 23, 2021. The affected devices were distributed across numerous U.S. states and territories, as well as in Italy, Norway, Sweden, France, the Netherlands, Germany, Spain, the United Kingdom, Portugal, South Korea, Singapore, and Hong Kong.
The specific CoolSculpting Elite System models (CS-S3-002-D-00 and CS-S3-002-D-00_R) and Surface 150 applicators are identified by their serial numbers and UDI codes. According to the recall record, no remedy has been specified for consumers or facilities that possess these devices.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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. Quantity: 911 systems (update 08/23/2021 = 1105 systems) 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; D01202016
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.