Recall Z-0131-2008 ยท GEX Powered Laser Surgical Instrument
AMS Innovative Center - San Jose
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
| Date | Feb 26, 2008 (initiated Jun 18, 2007) |
| Status | Terminated |
| Reason | Control knob break: The knob used to finely control the direction of the laser energy may break. |
| Root 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 | 611 units |
| Distribution | Worldwide Distribution - USA and Singapore. |
| FDA record | Open on fda.gov |