FDAFDA · Food and drugs·Recall number Z-0169-2015
Elite XPL (Pulsed Light) Handpiece for the Cynosure Elite MPX Laser System
Published November 12, 2014 · Recall initiated: October 9, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Cynosure, Inc.
- Distributor
- Worldwide Distribution - Nationwide Distribution and the countries of : Australia, Canada, France, Germany, Italy, Netherlands, Ukraine and UK.
- Lot
- All Serial numbers
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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