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Strata Skin Sciences, Inc. recalls XTRAC Excimer Laser, Model No. AL8000, AL10000 The intended use is targeted UVB phototherapy for treatment of the ski
Recalled April 5, 2017 · FDA recall Z-1455-2017 · Strata Skin Sciences
Hazard
When the Liquid Guide ( LLG) is not used according to the operator manual, the switch control wires may become loose and shorted. Shorted wires may lead to unintentional laser firing. · FDA Class II
Units
US - 1000 , Foreign - 612
Sold at
USA (nationwide) Distribution
Description
When the Liquid Guide ( LLG) is not used according to the operator manual, the switch control wires may become loose and shorted. Shorted wires may lead to unintentional laser firing.
Product
XTRAC Excimer Laser, Model No. AL8000, AL10000 The intended use is targeted UVB phototherapy for treatment of the skin conditions including psoriasis, vitiligo, atopic dermatitis, and leukoderma.
Manufacturer(s)
Strata Skin Sciences, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →