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Class 2 Device Recall Lumenis M22 System |
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Date Initiated by Firm |
November 17, 2015 |
Date Posted |
May 13, 2016 |
Recall Status1 |
Terminated 3 on November 30, 2016 |
Recall Number |
Z-1669-2016 |
Recall Event ID |
73765 |
510(K)Number |
K142860
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Product Classification |
Powered laser surgical instrument - Product Code GEX
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Product |
Lumenis M22 System Model Number: GA-0005400 (M22 IPL + YAG Module) with Acne Filter (KT-1014971). |
Code Information |
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 |
Recalling Firm/ Manufacturer |
Lumenis Ltd 13 Hayetzira St.,Yokneam Ind. Park Yokneam Israel
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Manufacturer Reason for Recall |
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.
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FDA Determined Cause 2 |
Device Design |
Action |
Customers were notified on November 17, 2015 by Customer Notification Letter and customers were asked to return the device. |
Quantity in Commerce |
33 filters |
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. |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database |
510(K)s with Product Code = GEX and Original Applicant = Lumenis Ltd.
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