Events

Recall of LIGHTSHEER DESIRE LASER

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by CLARION MEDICAL TECHNOLOGIES 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
    135923
  • Event Risk Class
    III
  • Event Initiated Date
    2015-03-13
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    A discrepancy in subject device product labeling exists. the programmed software settings were determined to be higher than those required for the model of handpiece deployed on patients. an examination of subject device lightsheer desire laser system labeling found the physician recommended treatment settings did not match the settings identified by the subject device software when specific patient skin types and hair color were selected. an inexperienced device operator would not be aware the treatment settings identified by the system software are incorrect.

Device

LIGHTSHEER DESIRE LASER
  • Model / Serial
    Model Catalog: LIGHTSHEER DESIRE (Lot serial: >10 contact mfg.)
  • Product Description
    Lightsheer desire laser
  • Manufacturer
    CLARION MEDICAL TECHNOLOGIES INC.

Manufacturer

CLARION MEDICAL TECHNOLOGIES INC.