Device product
Lumenis M22 System Model Number: GA-0005400 (M22 IPL + YAG Module) with Acne Filter (KT-1014971).
Z-1669-2016
Product summary
- Firm
- Lumenis Ltd
- Event
- Event 73765
- Status
- Terminated
- Classification
- Class II
- Quantity
- 33 filters
- Official record key
device-enforcement:Z-1669-2016
Official wording
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.
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
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.
Derived failure modes
-
Unknown
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.