The Recall Desk
HighFDA (Devices)·Z-1669-2016·Announced 2016-05-25

Lumenis M22 IPL Acne Filters Recalled for Superficial Burn Risk

Lumenis Ltd is recalling M22 IPL Acne Filters due to a risk of superficial burns when using the device.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk of superficial burns, which constitutes a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

Lumenis Ltd has announced a field action for the M22 IPL Acne Filters used with the Lumenis M22 IPL Hand Piece. The recall is being conducted due to the risk of superficial burns when using the device.

The affected products are the Lumenis M22 System Model Number: GA-0005400 (M22 IPL + YAG Module) with Acne Filter (KT-1014971). A total of 33 filters are involved in this recall. These filters were manufactured and distributed between August 04, 2015, and November 06, 2015.

The products were distributed in the states of GA, CA, CO, CT, KY, LA, MA, MN, NJ, NY, RI, and SC, as well as in the countries of Italy, Germany, France, and China. Users of these devices should stop using the affected filters and contact Lumenis Ltd for further instructions.

The recalled product

Product
Lumenis M22 System Model Number: GA-0005400 (M22 IPL + YAG Module) with Acne Filter (KT-1014971).
Manufacturer
Lumenis Ltd
Category
Medical Device — Laser / IPL Device
Hazard
Affected units
33

Distribution

Distributed in 12 states:

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