AMS Innovative Center - San Jose recalls GreenLight HPS (High Performance System) GreenLight XPS (Xcelerated Performance System) Manufactured by AMS, Solutio

Recalled January 30, 2013 · FDA recall Z-0700-2013 · 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. · FDA Class II

Units

389 devices, all model numbers.

Sold at

Worldwide Distribution.

Description

During electrical recertification testing it was found that the Voltage Scaling Board was non-conforming to the IEC 60601-1-2 standard.

Product

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.

Manufacturer(s)

AMS Innovative Center - San Jose

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →