Class 2 Device Recall GreenLight HPS Surgical Laser System

• Date Initiated by Firm: June 18, 2007
• Date Posted: February 26, 2008
• Recall Status: Terminated 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: 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