Recall of Picasso/Picasso Lite lasers

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by AMD Lasers, LLC.

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
    56330
  • Event Risk Class
    Class 2
  • Event Number
    Z-2349-2010
  • Event Initiated Date
    2010-04-15
  • Event Date Posted
    2010-09-10
  • Event Status
    Terminated
  • Event Country
  • Event Terminated Date
    2011-04-21
  • Event Source
    USFDA
  • Event Source URL
  • 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 is noncompliant with the federal laser product performance standard in certain requirements. the on/off key on some of the picasso/picasso lite lasers could be removed with force while the key was in the on position.
  • Action
    Letters, dated April 30, 2010, addressed to Dental Professionals were sent identifying the affected product and reason for the recall. The letter asked customers to check their units and, if applicable, AMD Lasers would replace the key assembly on their lasers. The service would be provided free of charge including round trip shipping charges to the corporate office. Customers are to call to schedule the service and obtain a RMA number and shipping instructions. Questions should be directed to 1-866-999-2635 or support@amdlasers.com.

Device

  • Model / Serial
    All associated serial numbers.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution
  • Product Description
    Picasso/Picasso Lite lasers || Intended use: Dentistry.
  • Manufacturer

Manufacturer

  • Manufacturer Address
    AMD Lasers, LLC, 7405 Westfield Blvd, Indianapolis IN 46240
  • Manufacturer Parent Company (2017)
  • Source
    USFDA