Company: Lumenis Limited.
Date of Enforcement Report: 5/6/2015
Class lI:
PRODUCT
Light Sheer Desire Diode Laser System with XC Handpiece Accessory options.
Recall Number Z-1519-2015
REASON
Device software treatment preset parameters for the XC treatment handpiece do not match the Operator Manual, and exceed recommended settings. Operator Manual parameters are lower than indicated for specific hair color and Fitzpatrick skin type resulting in insufficient treatment effect. May result in patient burns and hypopigmentation.
RECALLING FIRM/MANUFACTURER
Lumenis Limited, , IL on 3/25/2015 Voluntary: Firm Initiated recall is ongoing
VOLUME OF PRODUCT IN COMMERCE
117 units
DISTRIBUTION
Nationwide and Internationally
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