Reported Apr 5, 2017 · Terminated
XTRAC Excimer Laser, Model No. AL8000, AL10000 The intended use is targeted UVB phototherapy for treatment of the skin…
Strata Skin Sciences, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Strata Skin Sciences, Inc. · 2375 Camino Vida Roble Ste B · Carlsbad, CA · 92011-1556
Is this the product you have?
- 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.
- Lot codes and dates
- SN
1,000 of 1,000 codes
800078000980010800118001880019800208002580031800378003880042800438004780061800698007380074800778008480092800948009780099801028010480113801158011680119801218012280124801258012880131801348015080151801568015880160801618016480168801698017480176801778018380186801878019380195801998020380208802198022180224
- SN
- Amount recalled
- US - 1000 , Foreign - 612
Where it was sold
- Nationwide
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.
This product could cause temporary or reversible health problems — stop using it.
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