Events

Recall of Sonopet Console (Ultrasonic Surgical Aspirator System)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Stryker 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-2013-RN-00578-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-06-06
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00578-1
  • 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
    Stryker has received reports that the irrigation pump may not function and audible alarm may not sound. in cases where the irrigation pump fails, saline would not be provided to the tip and the tip may overheat.
  • Action
    Stryker will be replacing affected units with a loan unit until the unit is repaired.

Device

Sonopet Console (Ultrasonic Surgical Aspirator System)
  • Model / Serial
    Sonopet Console (Ultrasonic Surgical Aspirator System)Catalogue number: 5450852000Serial numbers: 1134000114, 1134000124, 1134000134, 1134000144, 1134000184, 1134000204 & 1209400174ARTG number: 174364
  • Product Classification
    General and Plastic Surgery Devices
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

Stryker Australia Pty Ltd
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    DHTGA