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.
FDA Recall Z-0700-2013 · Posted 2013-01-22
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Recalling FirmAMS Innovative Center - San Jose
Recall StatusTerminated
Product CodeGEX
Date Initiated2012-12-11
Date Terminated2014-02-13
Product Quantity389 devices, all model numbers.
Reason for Recall
During electrical recertification testing it was found that the Voltage Scaling Board was non-conforming to the IEC 60601-1-2 standard.
Firm 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.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Worldwide Distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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