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CoolSculpting System (also known as ZELTIQ Breeze System (2014-07-18)
- Starting date:
- July 18, 2014
- Posting date:
- August 8, 2014
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-40957
Recalled products
- CoolSculpting System (also known as ZELTIQ Breeze System
Reason
Adding hernia as a rare side effect to the user manual.
Affected products
A. CoolSculpting System (also known as ZELTIQ Breeze System
Lot or serial number
All lots, contact manufacturer.
Model or catalog number
- BRZ-CG1-CUB-110
- BRZ-CG1-CUD-110
Companies
- Manufacturer
-
Zeltiq Aesthetics, Inc.
4698 Willow Road
Pleasanton
94588
California
UNITED STATES