Lumenis Limited recalls Light Sheer Desire Diode Laser System with XC Handpiece Accessory options.

Recall date

March 25, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1519-2015

FDA classification

Class II

Brand / firm

Lumenis Limited

Sold / distributed

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.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Light Sheer Desire Diode Laser System with XC Handpiece Accessory options.