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U.S. Department of Health and Human Services

Class 2 Device Recall Cynosure

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  Class 2 Device Recall Cynosure see related information
Date Initiated by Firm October 09, 2014
Date Posted November 04, 2014
Recall Status1 Terminated 3 on March 26, 2015
Recall Number Z-0169-2015
Recall Event ID 69463
510(K)Number K091169  
Product Classification Powered laser surgical instrument - Product Code GEX
Product Elite XPL (Pulsed Light) Handpiece for the Cynosure Elite MPX Laser System
Code Information All Serial numbers
Recalling Firm/
Manufacturer		 Cynosure, Inc.
5 Carlisle Rd
Westford MA 01886
For Additional Information Contact
978-256-4200
Manufacturer 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
FDA Determined
Cause 2		 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 discontinue use of the laser system and to turn off the system immediately. They are also being instructed to leave the handpiece attached to the console and to not touch it. A Cynosure Field service engineer will then come to the office and remove the handpiece and return it to the Cynosure factory. In addition, the Cynosure Field Service engineer will install an interlock into the connector receptacle on the laser console. This interlock plug is an existing component that is used on systems that do not have an IPL handpiece in place. If your XPL pulsed light handpiece is not attached to the laser system please call Cynosure customer service (1-877-222-6822) to arrange for the handpiece to be returned and repaired.
Quantity in Commerce 322 units
Distribution Worldwide Distribution - Nationwide Distribution and the countries of : Australia, Canada, France, Germany, Italy, Netherlands, Ukraine and UK.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = GEX and Original Applicant = CYNOSURE, INC.
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