Events

Recall of ELITE MPX LASER SYSTEM - XPL HANDPIECE

According to Health Canada (via FOI), this recall involved a device in Canada 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
    32923
  • Event Risk Class
    II
  • Event Initiated Date
    2014-10-09
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    Cynosure has identified a potential situation where the user of the device could receive an electrical shock under certain conditions. 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.

Device

ELITE MPX LASER SYSTEM - XPL HANDPIECE
  • Model / Serial
    Model Catalog: 100-7009-700 (Lot serial: All serial numbers)
  • Product Description
    Elite XPL (Pulsed Light) Handpiece
  • Manufacturer
    CYNOSURE INC

Manufacturer

CYNOSURE INC
  • Manufacturer Address
    WESTFORD
  • Manufacturer Parent Company (2017)
    Hologic, Inc.
  • Source
    HC