Lumenis M22 System Model Number: GA-0005400 (M22 IPL + YAG Module) with Acne Filter (KT-1014971).
FDA device recall Z-1669-2016 · posted 2016-05-13 · Terminated
Recall details
- Recalling firm
- Lumenis Ltd
- 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.
- Action taken
- Customers were notified on November 17, 2015 by Customer Notification Letter and customers were asked to return the device.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- GEX
- Quantity affected
- 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.
- Date initiated
- 2015-11-17
- Date posted
- 2016-05-13
- Date terminated
- 2016-11-30
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Lumenis M22 System (K142860) | Lumenis, Ltd. | 2015-01-21 |