XTRAC Excimer Laser — Class II medical device recall Z-1455-2017
Terminated recall by Strata Skin Sciences, Inc., reported 2017-04-05, distributed nationwide. When the Liquid Guide ( LLG) is not used according to the operator manual, the switch control wires may become
| Recall number | Z-1455-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | FDA mandated |
| Recalling firm | Strata Skin Sciences, Inc., Carlsbad, CA, United States |
| Recall initiated | 2017-01-23 |
| Classified | 2017-03-27 |
| Reported by FDA | 2017-04-05 |
| Terminated | 2017-06-05 |
| Distributed | Nationwide (US) |
| Model numbers | AL10000, AL8000 |
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.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1455-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.