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.
This recall has been terminated (originally issued December 29, 2010).
- Company
- Ams Innovative Center San Jose
- Recall Initiated
- July 14, 2010
- Posted
- December 29, 2010
- Terminated
- January 3, 2011
- Recall Number
- Z-0834-2011
- Quantity
- 77 units
- Firm Location
- San Jose, CA
- Official Source
- View on FDA website ↗
Reason for Recall
Product not intended for release was distributed, which may result in old components, not built to specifications, or undergo final testing
Distribution
Worldwide Distribution, USA including TX, OH, MO, FL, MA, CA, IL, NY, VA, and the country of Australia.
Lot / Code Info
Part number 0010-2400, lot numbers 01P, 024P, and 025A
Root Cause
Labeling mix-ups
Action Taken
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.
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