Events

Recall of PERIOWAVE SYSTEM - HANDPIECE

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by ONDINE BIOMEDICAL 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
    14804
  • Event Risk Class
    III
  • Event Initiated Date
    2006-08-21
  • 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
    Handpiece supplied with periowave system has potential for damaging the optical surfaces by overtightening of the optical coupler. there is a potential for diminished light transmission from handpiece.

Device

PERIOWAVE SYSTEM - HANDPIECE
  • Model / Serial
    Model Catalog: PW1100 (Lot serial: D1401 to D1700); Model Catalog: PW1002 (Lot serial: D1401 to D1700)
  • Product Description
    Periowave Disinfection System Handpiece
  • Manufacturer
    ONDINE BIOMEDICAL INC.

Manufacturer

ONDINE BIOMEDICAL INC.