Events

Recall of Device Recall Lumenis

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

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
    34525
  • Event Risk Class
    Class 2
  • Event Number
    Z-0545-06
  • Event Initiated Date
    2006-02-01
  • Event Date Posted
    2006-03-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-12-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=44015
  • 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
    The bp/notch filter may be out of specification and may cause injury to the patient's eye due to high power (energy) delivered by the laser system during medical procedures.
  • Action
    On 7/26/04 and 2/1/06 the firm initiated the recall and its notification was via letters explaining the reason for the recall and requesting the product be returned for correction.

Device

Device Recall Lumenis
  • Model / Serial
    All codes manufactured prior to November 4, 2003.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide. The product was released for distribution to 1431 consignees worldwide. International consignees include: Australia, Canada, India, Netherlands, Argentina, France, Malaysia, Italy, Brazil, Mexico, China, Colombia, Thailand, Holland, Japan, and Venezuela. There were no shipments to U.S. Government facilities or foreign or Canadian distribution.
  • Product Description
    Lumenis brand Atlas, Corium, Elite, Elite Ultra 532nm Laser Systems; || Manufactured before November 4, 2003; || Manufactured by Lumenis, Inc., 3959 West 1820 South, Salt Lake City, Utah 84104
  • Manufacturer
    Lumenis Inc.

Manufacturer

Lumenis Inc.
  • Manufacturer Address
    Lumenis Inc., 2400 Condensa St, Santa Clara CA 95051-0901
  • Source
    USFDA