Cynosure, Inc.: Medical Device Recall in 2014 - (Recall #: Z-0169-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: October 9, 2014

Date Posted: November 12, 2014

Recall Number: Z-0169-2015

Event ID: 69463

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

Status: Terminated

Product Quantity: 322 units

Code Information:

All Serial numbers

Distribution Pattern:

Worldwide Distribution - Nationwide Distribution and the countries of : Australia, Canada, France, Germany, Italy, Netherlands, Ukraine and UK.

Voluntary or Mandated:

Voluntary: Firm initiated