CoolSculpting Elite System Software Error May Misreport Thermal Events
The CoolSculpting Elite System may incorrectly report or fail to report thermal events during treatment, potentially causing unnecessary re-treatment or continued use without awareness of a malfunction.
- Product
- CoolSculpting Elite System The CoolSculpting System SW release 2.0, SW release 3.0, SW release 3.0.1, SW release 3.0.2
- Category
- Medical Device
- Distribution
- 44 states