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U.S. Department of Health and Human Services

Class 2 Device Recall Lumenis M22 System

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 Class 2 Device Recall Lumenis M22 Systemsee related information
Date Initiated by FirmNovember 17, 2015
Date PostedMay 13, 2016
Recall Status1 Terminated 3 on November 30, 2016
Recall NumberZ-1669-2016
Recall Event ID 73765
510(K)NumberK142860 
Product Classification Powered laser surgical instrument - Product Code GEX
ProductLumenis 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
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.
FDA Determined
Cause 2		Device Design
ActionCustomers were notified on November 17, 2015 by Customer Notification Letter and customers were asked to return the device.
Quantity in Commerce33 filters
DistributionDistributed 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 CycleTPLC Device Report
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.
510(K) Database510(K)s with Product Code = GEX
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