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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 Device Recall GreenLight MoXy Fiber Optic see related information
Date Initiated by Firm July 14, 2010
Date Posted December 29, 2010
Recall Status1 Terminated 3 on January 03, 2011
Recall Number Z-0834-2011
Recall Event ID 56763
510(K)Number K100746  XPS-K092735)  
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 CA 95134-2011
For Additional Information Contact
408-943-0636 Ext. 6703
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
FDA Determined
Cause 2		 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 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 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 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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