Recall Z-0169-2015 ยท GEX Powered Laser Surgical Instrument
Cynosure, Inc.
Elite XPL (Pulsed Light) Handpiece for the Cynosure Elite MPX Laser System
| Date | Nov 4, 2014 (initiated Oct 9, 2014) |
| Status | Terminated |
| 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 |
| Root cause | Device Design |
| Action | Cynosure sent an Urgent Medical Device Recall Notification dated October 9, 2014, to all affected customers. They were also notified by phone. The letter identified the product the problem and the action needed to be taken by the customer. There are two methods for returning the Elite XPL handpieces. If the handpiece is NOT currently connected to the laser console, the customer will be asked to return it to the Cynosure office. If the handpiece is not connected there is no risk. If the handpiece is currently connected to the laser console, the customer is instructed to immediately discontinu |
| Quantity | 322 units |
| Distribution | Worldwide Distribution - Nationwide Distribution and the countries of : Australia, Canada, France, Germany, Italy, Netherlands, Ukraine and UK. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K091169 | ELITE MPX LASER SYSTEM WITH CRYO C Cynosure, Inc., May 13, 2009 |