Strata Skin Sciences, Inc. recalls XTRAC Excimer Laser, Model No. AL8000, AL10000 The intended use is targeted UVB phototherapy for treatment of the skin…

Recall date

January 23, 2017

Source

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

Recall number

Z-1455-2017

FDA classification

Class II

Brand / firm

Strata Skin Sciences, Inc.

Sold / distributed

USA (nationwide) Distribution

Why it was recalled

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.

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

What was recalled

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.