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.
Recall
- Recall Number
- Z-0834-2011
- Event Number
- 56763
- Firm
- AMS Innovative Center San Jose
- FEI Number
- 2937094
- Product Code
- GEX
- Status
- Terminated
- Root Cause
- Labeling mix-ups
- Initiated
- July 14, 2010
- Posted
- December 29, 2010
- Terminated
- January 3, 2011
- Address
- 3070 Orchard Dr, San Jose, CA, 95134-2011
Description
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.
Product not intended for release was distributed, which may result in old components, not built to specifications, or undergo final testing
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.
Worldwide Distribution, USA including TX, OH, MO, FL, MA, CA, IL, NY, VA, and the country of Australia.
77 units