Recall Z-0834-2011 ยท GEX Powered Laser Surgical Instrument
AMS Innovative Center - San Jose
GreenLight MoXy Fiber Optic, part number 0010-2400, for use with the GreenLight XPS Laser System, manufactured by American Medical Systems Inc., San Jose, CA The XPS Laser system is indicated for surgical incision and excision, vaporization, ablation, hemostasis and coagulation of soft tissue.
| Date | Dec 29, 2010 (initiated Jul 14, 2010) |
| Status | Terminated |
| Reason | Product not intended for release was distributed, which may result in old components, not built to specifications, or undergo final testing |
| Root cause | Labeling mix-ups |
| Action | American Medical Systems sent oral notifications that the product used for patient case evaluations was from the 2 year shelf life study. Products have been returned, as the product was with AMS field personnel. For questions regarding this recall call 847-855-6270. |
| Quantity | 77 units |
| Distribution | Worldwide Distribution, USA including TX, OH, MO, FL, MA, CA, IL, NY, VA, and the country of Australia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K100746 | FIBER ONE American Medical Systems, Jun 11, 2010 |