Recall Z-1455-2017 ยท GEX Powered Laser Surgical Instrument
Strata Skin Sciences, Inc.
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.
| Date | Mar 27, 2017 (initiated Jan 23, 2017) |
| Status | Terminated |
| 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. |
| Root cause | Radiation Control for Health and Safety Act |
| Action | STRATA Skin Sciences, Inc., planned action to bring defect into compliance: The Center for Devices and Radiological Health (CDRH) understands that the CAP involving 1000 domestic units and 612 international units will consist of the following: 1. Send Field Correction notification to all consignees by January 30, 2017, 2. Verify all consignees received the notification by February 10, 2017, 3. Ship all Rear Panel Boards to consignees by May 1, 2017, and 4. All corrective actions will be performed at no cost to the purchasers For further questions call Customer service phone no.: (877) |
| Quantity | US - 1000 , Foreign - 612 |
| Distribution | USA (nationwide) Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.