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U.S. Department of Health and Human Services

Class 2 Device Recall GreenLight HPS Surgical Laser System

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  Class 2 Device Recall GreenLight HPS Surgical Laser System see related information
Date Initiated by Firm June 18, 2007
Date Posted February 26, 2008
Recall Status1 Terminated 3 on March 23, 2010
Recall Number Z-0131-2008
Recall Event ID 38377
510(K)Number K010284  K062719  
Product Classification LASER ablation system component - Product Code GEX
Product American Medical Systems, Inc., (AMS) GreenLight HPS Fiber Optic (ADDStat) Part Number 0010-2090B. Fiber optic laser for treatment of BPH (Benign Prostatic Hyperplasia). AMS Innovative Center, San Jose, CA 95134
Code Information Part Number: 0010-2090B, Lot Numbers 705 N and 706 E
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		 Control knob break: The knob used to finely control the direction of the laser energy may break.
FDA Determined
Cause 2		 Process design
Action American Medical Systems, Inc. (AMS) issued Important: Medical Device Recall AMS Greenlight ADDStat Fibers notification letters to customers who have purchased the product on June 28, 2007. The customer letter requests recipients that the product use be discontinued, and the fibers be returned. The firm will send replacements.
Quantity in Commerce 611 units
Distribution Worldwide Distribution - USA and Singapore.
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 = LASERSCOPE
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