| 2022-06-09 |
Class II
|
Ongoing |
Z-1350-2022 |
CoolFit ZELTIQ Vacuum Applicator REF BRZ-AP1-066-000 |
— |
Executing a voluntary discontinuation and removal of parallel plate applicators due to an increase complaint rate for adverse event Paradoxical Hyperplasia (HP)… |
| 2022-06-09 |
Class II
|
Ongoing |
Z-1349-2022 |
CoolCurve+ ZELTIQ Vacuum Applicator REF BRZ-AP1-064-000 |
— |
Executing a voluntary discontinuation and removal of parallel plate applicators due to an increase complaint rate for adverse event Paradoxical Hyperplasia (HP)… |
| 2022-06-09 |
Class II
|
Ongoing |
Z-1348-2022 |
CoolCurve ZELTIQ Vaccum Applicator REF BRZ-AP1-062-000 |
— |
Executing a voluntary discontinuation and removal of parallel plate applicators due to an increase complaint rate for adverse event Paradoxical Hyperplasia (HP)… |
| 2022-06-09 |
Class II
|
Ongoing |
Z-1347-2022 |
CoolCore ZELTIQ Vacuum Applicator REF BRZ-AP1-063-000 |
— |
Executing a voluntary discontinuation and removal of parallel plate applicators due to an increase complaint rate for adverse event Paradoxical Hyperplasia (HP)… |
| 2022-06-09 |
Class II
|
Ongoing |
Z-1346-2022 |
CoolMax ZELTIQ Vacuum Applicator REF BRZ-AP1-080-000 |
— |
Executing a voluntary discontinuation and removal of parallel plate applicators due to an increase complaint rate for adverse event Paradoxical Hyperplasia (HP)… |
| 2021-07-05 |
Class II
|
Terminated |
Z-2383-2021 |
CoolSculpting Elite System The CoolSculpting System SW release 2.0, SW release 3.0, SW release 3.0.1, SW release 3.0.2 |
— |
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 … |