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

FDA device recall Z-1519-2015 · posted 2015-04-24 · Terminated

Recall details

Recalling firm

Lumenis Limited

Reason for recall

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.

Action taken

Lumenis Limited sent an Urgent Safety Advisory Notice dated March 25, 2015, to all affected customers. Customers were instructed that Lumenis is eliminating the potential risk of patient harm through a software upgrade and Operator Manual replacement. The software upgrade must be completed by a Lumenis-certified engineer as soon as possible. In the Interim, customers can continue to use their LightSheer DESIRE system by following the recommendations in the operator manual to always perform a test patch prior to a full treatment. Customers with questions were instructed to contact the Aesthetic Business Unit Product Manager. For questions regarding this recall call 801-656-2690.

Root cause

Software design

Status

Terminated

Product code

GEX

Quantity affected

117 units

Distribution

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, Kuw

Date initiated

2015-03-25

Date posted

2015-04-24

Date terminated

2016-06-15

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