Events

Recall of AVOXimeter System (a whole blood oximeter used during heart catheterisation procedures)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Zoll Medical 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-2016-RN-00618-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-05-12
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00618-1
  • 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
    The manufacturer, accriva diagnostics has confirmed that some avoximeter 1000e instruments shipped to customers from july 2015 and april 2016 may have been sent to customers with the diagnostic mode enabled. with the diagnostic mode enabled, users could mistakenly unlock features in the instrument software through a specific sequence of keystrokes. if these features are altered, there is a potential for erroneous results to be displayed. to date accriva has not received any reports of injuries or harm to users due to this issue. instruments in diagnostic mode perform per accriva’s specifications and all data generation is equivalent to those instruments properly set to user mode.
  • Action
    Zoll Medical is providing instructions for users to be able to identify the affected instruments. In the case where an affected instrument is identified, users should contact Zoll Technical Services to correct the settings. This action has been closed-out on 03/02/2017.

Device

AVOXimeter System (a whole blood oximeter used during heart catheterisation procedures)
  • Model / Serial
    AVOXimeter System (a whole blood oximeter used during heart catheterisation procedures)Product Code: AVOX1000ESerial Numbers: 5696-5725, 5816-5977ARTG Number: 262420
  • Manufacturer
    Zoll Medical Australia Pty Ltd

Manufacturer

Zoll Medical Australia Pty Ltd