FDA Medical Device Recalls (openFDA)
Cynosure, Inc.: Elite XPL (Pulsed Light) Handpiece for the Cynosure Elite MPX Laser System
- Recall number
- Z-0169-2015
- Recalling firm
- Cynosure, Inc.
- Product
- Elite XPL (Pulsed Light) Handpiece for the Cynosure Elite MPX Laser System
- Status
- Terminated
- Initiated
- 2014-10-09
- Posted
- 2014-11-04
- Terminated
- 2015-03-26
- 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 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
- 322 units
- Distribution
- Worldwide Distribution - Nationwide Distribution and the countries of : Australia, Canada, France, Germany, Italy, Netherlands, Ukraine and UK.
- Lot, serial or model codes
- All Serial numbers
- 510(k) numbers
- ["K091169"]
- PMA numbers
- not on file
- Product code
- GEX
- Firm FEI
- 1000120578
- Firm city
- Westford
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28