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
This recall has been terminated (originally issued February 26, 2008).
- Company
- Ams Innovative Center San Jose
- Recall Initiated
- June 18, 2007
- Posted
- February 26, 2008
- Terminated
- March 23, 2010
- Recall Number
- Z-0131-2008
- Quantity
- 611 units
- Firm Location
- San Jose, CA
- Official Source
- View on FDA website ↗
Reason for Recall
Control knob break: The knob used to finely control the direction of the laser energy may break.
Distribution
Worldwide Distribution - USA and Singapore.
Lot / Code Info
Part Number: 0010-2090B, Lot Numbers 705 N and 706 E
Root Cause
Process design
Action Taken
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.
More recalls by Ams Innovative Center San Jose
GreenLight HPS (High Performance System)
GreenLight XPS (Xcelerated Performance System)
Manufacture...
Jan 22, 2013
AMS brand GreenLight PV Laser System, Model-P/N: 0010-9230;
Product is manufactured and distributed...
Feb 14, 2011
GreenLight MoXy Fiber Optic, part number 0010-2400, for use with the GreenLight XPS Laser System, ma...
Dec 29, 2010