Events

Recall of Device Recall GreenLight MoXy Fiber Optic

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
    56763
  • Event Risk Class
    Class 2
  • Event Number
    Z-0834-2011
  • Event Initiated Date
    2010-07-14
  • Event Date Posted
    2010-12-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-01-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94467
  • 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
    Powered laser surgical instrument - Product Code GEX
  • Reason
    Product not intended for release was distributed, which may result in old components, not built to specifications, or undergo final testing.
  • Action
    American Medical Systems sent oral notifications that the product used for patient case evaluations was from the 2 year shelf life study. Products have been returned, as the product was with AMS field personnel. For questions regarding this recall call 847-855-6270.

Device

Device Recall GreenLight MoXy Fiber Optic
  • Model / Serial
    Part number 0010-2400, lot numbers 01P, 024P, and 025A
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution, USA including TX, OH, MO, FL, MA, CA, IL, NY, VA, and the country of Australia.
  • Product Description
    GreenLight MoXy Fiber Optic, part number 0010-2400, for use with the GreenLight XPS Laser System, manufactured by American Medical Systems Inc., San Jose, CA || The XPS Laser system is indicated for surgical incision and excision, vaporization, ablation, hemostasis and coagulation of soft tissue.
  • 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