Recall Z-0700-2013 ยท GEX Powered Laser Surgical Instrument
AMS Innovative Center - San Jose
GreenLight HPS (High Performance System) GreenLight XPS (Xcelerated Performance System) Manufactured by AMS, Solutions for Life Innovation Center. GreenLight HPS and XPS Surgical Lasers Systems and accessories are intended for use in endoscopic 532 nm laser resection of the prostate for the treatment of benign prostatic hyperplasia.
| Date | Jan 22, 2013 (initiated Dec 11, 2012) |
| Status | Terminated |
| Reason | During electrical recertification testing it was found that the Voltage Scaling Board was non-conforming to the IEC 60601-1-2 standard. |
| Root cause | Nonconforming Material/Component |
| Action | AMS sent "NOTICE OF DEVICE FIELD CORRECTIVE ACTION" letters dated December 20, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact the firm at 1-408-456-3320 for questions about this notification. |
| Quantity | 389 devices, all model numbers. |
| Distribution | Worldwide Distribution. |
| FDA record | Open on fda.gov |