Z-0169-2015 Class II Terminated
FDA device recall Z-0169-2015 was initiated by Cynosure, Inc. on October 9, 2014 and is designated Class II. Reason for recall: If the laser system is turned on and the user adjusts, installs or removes the XPL pulsed light handpiece, there is a potential risk of an electrical shock The recall status is terminated (terminated March 26, 2015). Affected quantity: 322 units.
Recall Details
- Product Type
- Devices
- Report Date
- November 12, 2014
- Initiation Date
- October 9, 2014
- Termination Date
- March 26, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 322 units
Product Description
Elite XPL (Pulsed Light) Handpiece for the Cynosure Elite MPX Laser System
Reason for Recall
If the laser system is turned on and the user adjusts, installs or removes the XPL pulsed light handpiece, there is a potential risk of an electrical shock
Distribution Pattern
Worldwide Distribution - Nationwide Distribution and the countries of : Australia, Canada, France, Germany, Italy, Netherlands, Ukraine and UK.
Code Information
All Serial numbers