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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 Recall
GreenLight HPS Surgical Laser System
see related information
Date Posted February 26, 2008
Recall Status1 Terminated on March 23, 2010
Recall Number Z-0131-2008
Recall Event ID 38377
Premarket Notification
510(K) Numbers
K010284  K062719 
Product Classification Powered Laser Surgical Instrument - 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, California 95134-2011
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
DESIGN: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = GEX and Original Applicant = LASERSCOPE
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