Reported May 25, 2016 · Terminated
Lumenis M22 System Model Number: GA-0005400 (M22 IPL + YAG Module) with Acne Filter (KT-1014971).
Lumenis Ltd.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Lumenis Ltd · 13 Hayetzira St.,Yokneam Ind. Park · Yokneam, N/A · N/A
Is this the product you have?
- Lumenis M22 System Model NumberGA-0005400 (M22 IPL + YAG Module) with Acne Filter (KT-1014971)
- Lot codes and dates
- Lumenis M22 System Model NumberGA-0005400 (M22 IPL + YAG Module) All Acne Filters
- manufactured and Distributed BetweenAugust 04 2015 and November 06 2015
- Amount recalled
- 33 filters
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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