FDA Device recall Z-1455-2017
XTRAC Excimer Laser, Model No. AL8000, AL10000 The intended use is targeted UVB phototherapy for treatment of the skin conditions including…
- FDA Device
- Class II
- terminated
- Published 2017-04-05
On 2017-04-05 the FDA classified a Class II recall of XTRAC Excimer Laser, Model No. AL8000, AL10000 The intended use is targeted UVB phototherapy for treatment of the skin conditions including… by Strata Skin Sciences, citing 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 fir….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1455-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-01-23 |
| Published | 2017-04-05 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Strata Skin Sciences |
| Distribution | US |
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
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.
Identifiers
| code_info | SN 80007 80009 80010 80011 80018 80019 80020 80025 80031 80037 80038 80042 80043 80047 80061 80069 800…SN 80007 80009 80010 80011 80018 80019 80020 80025 80031 80037 80038 80042 80043 80047 80061 80069 80073 80074 80077 80084 80092 80094 80097 80099 80102 80104 80113 80115 80116 80119 80121 80122 80124 80125 80128 80131 80134 80150 80151 80156 80158 80160 80161 80164 80168 80169 80174 80176 80177 80183 80186 80187 80193 80195 80199 80203 80208 80219 80221 80224 80225 80232 80238 80248 80249 80256 80257 80258 80259 80261 80278 80280 80293 80294 80298 80304 80310 80312 80314 80315 80317 80326 80327 80334 80336 80339 80348 80351 80352 80355 80358 80359 80360 80366 80369 80370 80372 80378 80379 80381 80386 80388 80391 80394 80397 80398 80402 80414 80417 80420 80426 80427 80430 80434 80435 80437 80440 80451 80452 80456 80462 80463 80466 80472 80477 80479 80480 80486 80493 80496 80497 80498 80499 80501 80503 80504 80507 80512 80513 80525 80529 80530 80 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1455-2017%22
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