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Terminated

Lumenis M22 System Model Number: GA-0005400 (M22 IPL + YAG Module) with Acne Filter (KT-1014971).

FDA Recall Z-1669-2016 · Posted 2016-05-13

Recalling FirmLumenis Ltd
Recall StatusTerminated
Product CodeGEX
Date Initiated2015-11-17
Date Terminated2016-11-30
Product Quantity33 filters

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.

Firm Action

Customers were notified on November 17, 2015 by Customer Notification Letter and customers were asked to return the device.

Root Cause

Device Design

Distribution Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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