Events

Recall of TRITON SELF CONTAINED DENTAL SYSTEM

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by ASI MEDICAL 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
    97136
  • Event Risk Class
    II
  • Event Initiated Date
    2013-11-25
  • 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
    Field correction to the unit. addition of a 100 psi pressure relief valve and service warning label. operational pressure in excess of 100 psi can result in rupture of the air reservoir tank.

Device

TRITON SELF CONTAINED DENTAL SYSTEM
  • Model / Serial
    Model Catalog: 2020 (Lot serial: 50341 to 592066)
  • Product Description
    SEAC Dental System - Model 2020
  • Manufacturer
    ASI MEDICAL INC.

Manufacturer

ASI MEDICAL INC.
  • Manufacturer Address
    ENGLEWOOD
  • Manufacturer Parent Company (2017)
    Asi Medical Inc.
  • Source
    HC