Recall Z-1669-2016
Lumenis Ltd · initiated November 17, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Lumenis M22 System Model Number: GA-0005400 (M22 IPL + YAG Module) with Acne Filter (KT-1014971).
Codes / lots: 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
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: Device Design
Action taken
Customers were notified on November 17, 2015 by Customer Notification Letter and customers were asked to return the device.
Details
- Recall number
- Z-1669-2016
- Initiated
- November 17, 2015
- Posted by FDA
- May 13, 2016
- Terminated
- November 30, 2016
- Product code
- GEX – Powered Laser Surgical Instrument
- 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.
- Recalling firm
- Lumenis Ltd