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Lumenis Limited recalls Light Sheer Desire Diode Laser System with XC Handpiece Accessory options.
Recalled May 6, 2015 · FDA recall Z-1519-2015 · Lumenis
Hazard
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. · FDA Class II
Units
117 units
Sold at
Worldwide distribution. US nationwide (to OR, NM, NY, IL, and CO), Switzerland, Canada, Italy, Great Britain, United Arab Emirates, France, Belgium, India, Israel, Japan, Portugal, Czech Republic, Kuwait, Germany, Spain, Georgia, Armenia, Slovenia, New Zealand, Saudi Arabia, and Russian Federation.
Description
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.
Product
Light Sheer Desire Diode Laser System with XC Handpiece Accessory options.
Manufacturer(s)
Lumenis Limited
Made in
Israel
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →