Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

American Medical Systems, Inc., (AMS) GreenLight HPS Fiber Optic (ADDStat) Part Number 0010-2090B. Fiber optic laser for treatment of BPH (Benign Prostatic Hyperplasia). AMS Innovative Center, San Jose, CA 95134

FDA Recall Z-0131-2008 · Posted 2008-02-26

Recalling FirmAMS Innovative Center - San Jose
Recall StatusTerminated
Product CodeGEX
Date Initiated2007-06-18
Date Terminated2010-03-23
Product Quantity611 units

Reason for Recall

Control knob break: The knob used to finely control the direction of the laser energy may break.

Firm Action

American Medical Systems, Inc. (AMS) issued Important: Medical Device Recall AMS Greenlight ADDStat Fibers notification letters to customers who have purchased the product on June 28, 2007. The customer letter requests recipients that the product use be discontinued, and the fibers be returned. The firm will send replacements.

Root Cause

Process design

Distribution Pattern

Worldwide Distribution - USA and Singapore.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K062719GREENLIGHT HPS SERIES SURGICAL LASER SYSTEM & ACCESSORIESLaserscope · 2006-12-01K010284LYRA G SERIES SURGICAL LASER SYSTEM (SL SERIES Q-SWITCHED ND:YAG CONFIGURATION)Laserscope · 2001-05-01

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑