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
    34574
  • Event Risk Class
    Class 2
  • Event Number
    Z-0556-06
  • Event Initiated Date
    2006-02-09
  • Event Date Posted
    2006-02-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-08-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=44121
  • 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
    During hair removal treatment, patients' skin can experience burns due to debris accumulating on the sapphire crystal tip.
  • Action
    On 2/9/06, the firm initiated the recall and its notification was via letters informing its customers of the corrective action. In May 2005, Lumenis mailed a 'Dear Doctor' letter to LightSheer Diode Laser System customers describing more detailed cleaning procedures to be used on the sapphire tips due to skin burns patients' were experiencing from debris build-up on the tip.

Device

Device Recall Lumenis
  • Model / Serial
    All codes, All serial numbers
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The product was released for distribution to 3,426 consignees nationwide. There are 48 international consignees.
  • Product Description
    Lumenis brand LightSheer Pulsed Diode Array Laser System; All serial numbers; || Manufactured by RH USA, Inc., 201 Lindbergh Avenue, Livermore, California 94551
  • Manufacturer
    Lumenis Inc.

Manufacturer

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