Events

Recall of Cynosure

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Cynosure, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    69463
  • Event Risk Class
    Class 2
  • Event Number
    Z-0169-2015
  • Event Initiated Date
    2014-10-09
  • Event Date Posted
    2014-11-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-03-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=130718
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Powered laser surgical instrument - Product Code GEX
  • 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.
  • 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.

Device

Cynosure
  • Model / Serial
    All Serial numbers
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - Nationwide Distribution and the countries of : Australia, Canada, France, Germany, Italy, Netherlands, Ukraine and UK.
  • Product Description
    Elite XPL (Pulsed Light) Handpiece for the Cynosure Elite MPX Laser System
  • Manufacturer
    Cynosure, Inc.

Manufacturer

Cynosure, Inc.
  • Manufacturer Address
    Cynosure, Inc., 5 Carlisle Rd, Westford MA 01886
  • Manufacturer Parent Company (2017)
    Hologic Inc
  • Source
    USFDA