Device product
Elite XPL (Pulsed Light) Handpiece for the Cynosure Elite MPX Laser System
Z-0169-2015
Product summary
- Firm
- Cynosure, Inc.
- Event
- Event 69463
- Status
- Terminated
- Classification
- Class II
- Quantity
- 322 units
- Official record key
device-enforcement:Z-0169-2015
Official wording
Reason: 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
Code information: All Serial numbers
Distribution pattern: Worldwide Distribution - Nationwide Distribution and the countries of : Australia, Canada, France, Germany, Italy, Netherlands, Ukraine and UK.
Derived failure modes
-
Unknown
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