Strata Skin Sciences Recalls XTRAC Excimer Lasers Due to Shorted Wires
Strata Skin Sciences is recalling XTRAC Excimer Lasers because loose switch control wires may short, leading to unintentional laser firing.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (laser device) where unintentional firing could cause injury, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Strata Skin Sciences, Inc. is recalling XTRAC Excimer Lasers, Models AL8000 and AL10000. The intended use of these devices is targeted UVB phototherapy for the treatment of skin conditions including psoriasis, vitiligo, atopic dermatitis, and leukoderma.
The recall is due to a defect where the switch control wires may become loose and shorted if the Liquid Guide (LLG) is not used according to the operator manual. Shorted wires may lead to unintentional laser firing.
Approximately 1,000 units were distributed in the United States and 612 units were distributed in foreign countries. The devices were distributed nationwide in the USA. Consumers and healthcare providers should check their device serial numbers against the list provided by the manufacturer and contact Strata Skin Sciences for instructions on corrective action.
The recalled product
- 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
- Strata Skin Sciences, Inc.
- Category
- Medical Device — Laser Therapy
Distribution
Distributed nationwide across the United States.
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