Recall Z-2502-2010 ยท GEX Powered Laser Surgical Instrument
AMS Innovative Center - San Jose
GreenLight HPS fiber optics, Model Number 10-2090, manufactured by AMS (American Medical Systems), San Jose, CA. Potentially Mislabeled as GreenLight PV 10-2079
| Date | Sep 25, 2010 (initiated Jan 22, 2010) |
| Status | Terminated |
| Reason | Product may be packed with incorrect external or internal labels and/or missing product insert. |
| Root cause | Labeling mix-ups |
| Action | Notification issued via letter with instructions and response sheet through certified mail on 01/12/2010. |
| Quantity | 11668 units |
| Distribution | Product was distributed to 148 medical facilities throughout the US. and 6 consignees in Great Britain, Canada and Australia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K062719 | GREENLIGHT HPS SERIES SURGICAL LASER SYSTEM & ACCESSORIES Laserscope, Dec 1, 2006 |