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U.S. Department of Health and Human Services

Class 2 Device Recall GreenLight MoXy Fiber Optic

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 Class 2 Recall
GreenLight MoXy Fiber Optic
see related information
Date Posted December 29, 2010
Recall Status1 Terminated on January 03, 2011
Recall Number Z-0834-2011
Recall Event ID 56763
Premarket Notification
510(K) Number
K100746 
Product Classification Powered Laser Surgical Instrument - Product Code GEX
Product 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.
Code Information Part number 0010-2400, lot numbers 01P, 024P, and 025A
Recalling Firm/
Manufacturer
AMS Innovative Center - San Jose
3070 Orchard Dr
San Jose, California 95134-2011
Manufacturer Reason
for Recall
Product not intended for release was distributed, which may result in old components, not built to specifications, or undergo final testing
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 in Commerce 77 units
Distribution Worldwide Distribution, USA including TX, OH, MO, FL, MA, CA, IL, NY, VA, and the country of Australia.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
510(K) Database 510(K)s with Product Code = GEX and Original Applicant = AMERICAN MEDICAL SYSTEMS
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