Recall Z-1669-2016 ยท GEX Powered Laser Surgical Instrument
Lumenis Ltd
Lumenis M22 System Model Number: GA-0005400 (M22 IPL + YAG Module) with Acne Filter (KT-1014971).
| Date | May 13, 2016 (initiated Nov 17, 2015) |
| Status | Terminated |
| 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. |
| Root cause | Device Design |
| Action | Customers were notified on November 17, 2015 by Customer Notification Letter and customers were asked to return the device. |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K142860 | Lumenis M22 System Lumenis, Ltd., Jan 21, 2015 |