Recall Z-1519-2015 ยท GEX Powered Laser Surgical Instrument
Lumenis Limited
Light Sheer Desire Diode Laser System with XC Handpiece Accessory options.
| Date | Apr 24, 2015 (initiated Mar 25, 2015) |
| Status | Terminated |
| 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. |
| Root cause | Software design |
| Action | 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 Aesth |
| Quantity | 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, Kuwait, Germany, Spain, Georgia, Armenia, Slovenia, New Zealand, Saudi Arabia, and Russian Federation |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K003614 | LIGHTSHEER PULSED DIODE ARRAY LASER SYSTEM Coherent Star, Mar 13, 2001 |