FDAClass IINovember 12, 2014

Elite XPL recall

Elite XPL (Pulsed Light) Handpiece for the Cynosure Elite MPX Laser System

Why was Elite XPL recalled?

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 should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

All Serial numbers

Product
Elite XPL (Pulsed Light) Handpiece for the Cynosure Elite MPX Laser System
Recalling firm
Cynosure, Inc.
Quantity
322 units
Distribution
Worldwide Distribution - Nationwide Distribution and the countries of : Australia, Canada, France, Germany, Italy, Netherlands, Ukraine and UK.
Recall date
November 12, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls