Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
GreenLight HPS (High Performance System) GreenLight XPS (Xcelerated Performance System) Recalled by AMS Innovative Center - San Jose Due to During electrical recertification testing it was found that...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact AMS Innovative Center - San Jose directly.
Affected 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.
Quantity: 389 devices, all model numbers.
Why Was This Recalled?
During electrical recertification testing it was found that the Voltage Scaling Board was non-conforming to the IEC 60601-1-2 standard.
Where Was This Sold?
Worldwide Distribution.
About AMS Innovative Center - San Jose
AMS Innovative Center - San Jose has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report