Events

Recall of Water Filters on Cavitron Scalers and Air Polishing Units (ultrasonic peridontic scaler)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Dentsply (Australia) Pty Ltd.

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
    RC-2012-RN-00881-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2012-09-05
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-00881-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    Dentsply australia pty ltd has been advised that a limited number of water filters used on cavitron scaler and air polishing units overseas have developed leaks.
  • Action
    Dentsply are providing replacement filters for all affected units.

Device

Water Filters on Cavitron Scalers and Air Polishing Units (ultrasonic peridontic scaler)
  • Model / Serial
    Water Filters on Cavitron Scalers and Air Polishing Units (ultrasonic peridontic scaler)ARTG Number: 137867
  • Manufacturer
    Dentsply (Australia) Pty Ltd

Manufacturer

Dentsply (Australia) Pty Ltd