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.
FDA Recall Z-0834-2011 · Posted 2010-12-29
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Recalling FirmAMS Innovative Center - San Jose
Recall StatusTerminated
Product CodeGEX
Date Initiated2010-07-14
Date Terminated2011-01-03
Product Quantity77 units
Reason for Recall
Product not intended for release was distributed, which may result in old components, not built to specifications, or undergo final testing
Firm 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.
Root Cause
Labeling mix-ups
Distribution Pattern
Worldwide Distribution, USA including TX, OH, MO, FL, MA, CA, IL, NY, VA, and the country of Australia.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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