Z-1669-2016 Class II Terminated
FDA device recall Z-1669-2016 was initiated by Lumenis Ltd on November 17, 2015 and is designated Class II. 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. The recall status is terminated (terminated November 30, 2016). Affected quantity: 33 filters.
Recall Details
- Product Type
- Devices
- Report Date
- May 25, 2016
- Initiation Date
- November 17, 2015
- Termination Date
- November 30, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 33 filters
Product Description
Lumenis M22 System Model Number: GA-0005400 (M22 IPL + YAG Module) with Acne Filter (KT-1014971).
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.
Distribution Pattern
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.
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