Events

Recall of Device Recall Lumenis M22 System

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

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
    73765
  • Event Risk Class
    Class 2
  • Event Number
    Z-1669-2016
  • Event Initiated Date
    2015-11-17
  • Event Date Posted
    2016-05-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-11-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144941
  • 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
    Lumenis ltd announces a field action of the m22 ipl acne filters for the lumenis m22 ipl hand piece due to the risk of superficial burns when using the device.
  • Action
    Customers were notified on November 17, 2015 by Customer Notification Letter and customers were asked to return the device.

Device

Device Recall Lumenis M22 System
  • Model / Serial
    Lumenis M22 System Model Number: GA-0005400 (M22 IPL + YAG Module) All Acne Filters manufactured and Distributed Between: August 04 2015 and November 06 2015
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed in the states of GA, CA, CO, CT, KY, LA, MA, MN, NJ, NY, RI, and SC, and the countries of Italy, Germany, France, and China.
  • Product Description
    Lumenis M22 System Model Number: GA-0005400 (M22 IPL + YAG Module) with Acne Filter (KT-1014971).
  • Manufacturer
    Lumenis Ltd

Manufacturer

Lumenis Ltd
  • Manufacturer Address
    Lumenis Ltd, 13 Hayetzira St.,Yokneam Ind. Park, Yokneam Israel
  • Manufacturer Parent Company (2017)
    Laguna Holdco Ltd
  • Source
    USFDA