Events

Recall of Device Recall GreenLight HPS Surgical Laser System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by AMS Innovative Center - San Jose.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    38377
  • Event Risk Class
    Class 2
  • Event Number
    Z-0131-2008
  • Event Initiated Date
    2007-06-18
  • Event Date Posted
    2008-02-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-03-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=53506
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    LASER ablation system component - Product Code GEX
  • Reason
    Control knob break: the knob used to finely control the direction of the laser energy may break.
  • 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.

Device

Device Recall GreenLight HPS Surgical Laser System
  • Model / Serial
    Part Number: 0010-2090B, Lot Numbers 705 N and 706 E
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA and Singapore.
  • Product Description
    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
  • Manufacturer
    AMS Innovative Center - San Jose

Manufacturer

AMS Innovative Center - San Jose
  • Manufacturer Address
    AMS Innovative Center - San Jose, 3070 Orchard Dr, San Jose CA 95134-2011
  • Source
    USFDA