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
    36188
  • Event Risk Class
    Class 2
  • Event Number
    Z-0028-2007
  • Event Initiated Date
    2006-08-29
  • Event Date Posted
    2006-10-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-01-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=48150
  • 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
    laser ablation - Product Code GEX
  • Reason
    Device lacks the black indicator markings on the metal tip and there is the potential for fiber degradation (detachment of the metal cap, and the fiber lasing straight) during use.
  • Action
    On 8/26/06, the firm initiated the recall and its notification was via letters and phone calls requesting return of affected product.

Device

Device Recall Lumenis
  • Model / Serial
    Lot/Batch Numbers:   37600206, 38030206, 38470206, 39110306, 39660406, 40480506, 41040506, 42110606, 42550706, 37640206, 38120206, 38480206, 39200306, 39670406, 40490506, 41050506, 42120606, 42560706, 37650206, 38150206, 38510206, 39210306, 39680406, 40520506, 41080506, 42200606, 42570706, 37660206, 38160206, 38520206, 39220306, 39690406, 40530506, 41090506, 42210606, 42580706, 37700206, 38170206, 38530206, 39240306, 39770406, 40570506, 41100506, 42280606, 42650706, 37710206, 38200206, 38700306, 39250306, 39800406, 40580506, 41210506, 42290606, 42680706, 37720206, 38210206, 38710306, 39260306, 39810406, 40590506, 41310506, 42300606, 42740706, 37730206, 38230206, 38720306, 39270306, 39820406, 40600506, 41360506, 42310606, 42810706, 37740206, 38240206, 38730306, 39280306, 39830406, 40610506, 41390506, 42320606, 42890706, 37750206, 38300206, 38740306, 39460306, 39840406, 40690506, 41450506, 42330606, 43000706, 37760206, 38310206, 38800306, 39470306, 39880406, 40710506, 41470506, 42350606, 43010706, 37770206, 38380206, 38810306, 39530306, 39890406, 40720506, 41500506, 42360606, 43060706, 37800206, 38390206, 38830306 39540306, 39900406, 40730506, 41610606, 42380606, 43150706, 37810206, 38400206, 38840306, 39550306, 40180406, 40930506, 41750606, 42410606, 43190706, 37820206, 38410206, 38920306, 39560306, 40200406, 40940506, 41880606, 42420606, 43200706, 37890206, 38420206, 38930306, 39570306, 40340406, 40960506, 41890606, 42430606, 43210706, 37910206, 38430206, 38970306 39580306, 40390406, 40970506, 41900606, 42460706, 43220706, 37960206, 38440206, 38980306, 39590306, 40430406, 40980506, 41930606, 42490706, 43270706, 37970206, 38450206, 38990306, 39600306, 40460506, 41020506, 41990606, 42500706, 43280706, 37980206, 38460206, 39000306, 39650306, 40470506, 41030506, 42000606, 42540706, 43410706
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide, including USA, Japan, Europe, Hong Kong, Russia and Canada.
  • Product Description
    Lumenis brand DuoTome SideLite¿ 550 Micron Delivery System; laser systems for ablating soft tissue. || Catalog Number: 0641-800-01; Manufactured by Lumenis, Inc., 2400 Condensa Street, Santa Clara, CA
  • Manufacturer
    Lumenis Inc.

Manufacturer

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