FDA-Device2013-01-30Class II
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.
AMS Innovative Center - San Jose
Hazard
During electrical recertification testing it was found that the Voltage Scaling Board was non-conforming to the IEC 60601-1-2 standard.
Sold states
Worldwide Distribution.
Affected count
389 devices, all model numbers.
Manufactured in
3070 Orchard Dr, N/A, San Jose, CA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0700-2013Don't want to check this manually?
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