Events

Recall of CANDELA MID IR DIODE LASER SYSTEM WITH DCD (SMOOTHBEAM)

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

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
    23401
  • Event Risk Class
    II
  • Event Initiated Date
    2003-12-13
  • 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 resistor (r46) could be missing on an unknown quantity of cpu pcb used within the smoothbeam laser system. could lead to the failure of the cryogen delivery system to detect the absence of cryogen during las.

Device

CANDELA MID IR DIODE LASER SYSTEM WITH DCD (SMOOTHBEAM)
  • Model / Serial
    Model Catalog: (Lot serial: 13 SERIAL # ABOVE 9914-0820...); Model Catalog: (Lot serial: 394/434/451/503/510); Model Catalog: (Lot serial: -259/311/323/324/327/332/356); Model Catalog: (Lot serial: 9914-0820-208)
  • Product Description
    MID IR DIODE LASER WITH DCD SMOOTHBEAM
  • Manufacturer
    CANDELA CORPORATION

Manufacturer

CANDELA CORPORATION
  • Manufacturer Address
    WAYLAND
  • Source
    HC