Events

Recall of GYNELASE DIODE LASER SYSTEM

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by LUMENIS LTD..

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
    29670
  • Event Risk Class
    II
  • Event Initiated Date
    2001-01-23
  • 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
    An incident occurred where a disposible tip became detached from the rest of the device and had to be removed from the uterus of the patient.

Device

GYNELASE DIODE LASER SYSTEM
  • Model / Serial
    Model Catalog: (Lot serial: )
  • Product Description
    Gynelase Diode Laser System
  • Manufacturer
    LUMENIS LTD.

Manufacturer

LUMENIS LTD.