Events

Recall of SOFT TISSUE DIODE LASER

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by ZOLAR TECHNOLOGY & MFG CO. 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
    125935
  • Event Risk Class
    III
  • Event Initiated Date
    2013-11-12
  • 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
    The laservision product number affected is f22.P1co3.5000. during a routine quality check it was determined that the protection level of the glasses is less than what is marked on the side of the product.

Device

SOFT TISSUE DIODE LASER
  • Model / Serial
    Model Catalog: PHOTON PLUS (Lot serial: NA); Model Catalog: PHOTON (Lot serial: NA)
  • Product Description
    PHOTON AND PHOTON PLUS DENTAL DIODE LASER
  • Manufacturer
    ZOLAR TECHNOLOGY & MFG CO. INC.

Manufacturer

ZOLAR TECHNOLOGY & MFG CO. INC.
  • Manufacturer Address
    MISSISSAUGA
  • Source
    HC