Events

Recall of 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
    34556
  • Event Risk Class
    Class 2
  • Event Number
    Z-0529-06
  • Event Initiated Date
    2005-04-08
  • Event Date Posted
    2006-02-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-12-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=44081
  • 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
    Software anomaly recorded incorrect filter in patient database and this may lead to patient skin burns.
  • Action
    On 4/8/05, the firm initiated the recall and its notification was via letters informing its customers of the corrective action.

Device

Lumenis
  • Model / Serial
    Software versions lower than 2.02 All serial numbers; All codes
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The product was released for distribution to 124 consignees nationwide. One international consignee includes: New Zealand. There were no shipments to U.S. Government facilities or foreign or Canadian distribution.
  • Product Description
    Lumenis brand Lumenis One System with Multi-Spot Nd:YAG, LightSheer and Universal IPL; Manufactured by Lumenis, Ltd, 13 Hayetzira Street, Yokneam Industrial Park, Yokneam, Israel 20692
  • Manufacturer
    Lumenis Inc.

Manufacturer

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