Events

Recall of SONIC IRRIGATOR - PCF SYSTEM

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by SOUTHMEDIC 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
    143019
  • Event Risk Class
    II
  • Event Initiated Date
    2013-07-02
  • 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 potential for electrical fire. some of the affected models contain faulty plugs in the drain valve. moisture that collects on the plug can lead to a short circuit with the potential for an electrical fire to ensue.

Device

SONIC IRRIGATOR - PCF SYSTEM
  • Model / Serial
    Model Catalog: MED11121 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: MED11131 (Lot serial: >10 NUMBERS CONTACT MFG)
  • Product Description
    SONIC IRRIGATOR PCF SYSTEM
  • Manufacturer
    SOUTHMEDIC INC.

Manufacturer

SOUTHMEDIC INC.